Sabura Matthews

Sabura Matthews, a visionary in digital strategy for global patient safety, shares her transformative journey from the fast-paced world of trauma nursing to the strategic realm of pharmacovigilance. Her story begins amidst the chaotic energy of Philadelphia's trauma centers, where she honed her critical care skills. Facing professional challenges and yearning for growth, Sabura transitioned into clinical data management at SmithKline Beecham, where she discovered the powerful intersection of technology and patient safety. Her evolution serves as an inspiring blueprint for those looking to pivot their careers while leveraging their unique expertise.

Listeners will gain insights into the dynamic nature of pharmacovigilance careers as we dissect the shifting landscape over the years. The rise of AI and the prevalence of vendor outsourcing have redefined opportunities, particularly in roles focused on case processing. Sabura shares valuable strategies for career development, emphasizing the importance of proactive learning. From attending industry events to consuming educational content, she highlights the need to continuously expand one's skill set. This episode promises actionable advice for anyone eager to navigate and succeed in an ever-evolving industry.

We also explore the complexities of project management and the critical role of digital tools in enhancing operational efficiency. The conversation dives into the nuances of balancing outsourcing with maintaining control over essential processes, stressing the danger of excessive dependence on vendors. Sabura's insights offer a guide to optimizing internal operations and ensuring compliance with the latest regulatory and technological standards. Listen to this enriching dialogue for thoughtful perspectives on aligning digital solutions with business needs, fostering strong vendor relationships, and ultimately achieving successful project outcomes.

Transcript

Speaker 1 0:16

Welcome to another episode of Innovation and the Future of Pharmacovigilance, a podcast series brought to you by Trudientalks. I'm your host, indy Alwalia, and I'm delighted to navigate the dynamic world of pharma divisions and risk management with you. But first, as traditional, a quick disclaimer the opinions expressed in this episode are solely those of the individual guests and do not necessarily reflect the official views of Truliant Consulting or indeed their own company. We're all about fostering insightful conversations here at Truliant Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement If you're seeking professional advice for specific situations, we encourage you to go to our experts.

Speaker 1 1:05

Please remember this podcast content is meant for informational and educational purposes only. So today I'm so excited because we have Sabra Matthews, who is Head of Digital Strategy at Global Patient Safety Operations at Cicada, as our guest speaker. Sabra, welcome to the podcast.

Speaker 2 1:34

Thank you so much, Indy.

Speaker 1 1:37

So, as is tradition with this podcast, I have to ask how did you get into PV this podcast? I have thoughts.

Speaker 2 1:45

How did you get into PV? So my story is a little bit different, but not so much. So, like a lot of people in PV, you know I started out as a clinician. You know. I know a lot of folks are, you know, clinicians doctors, nurses, pharmacists and the like. So I started out my career as a registered nurse in emergency medicine and critical care. So you know I started out as a trauma nurse. You know, working in the emergency rooms of Philadelphia really had an opportunity to hone my clinical skill set in that environment, did some time in adult ICU and pediatric ICUs, also in the Philadelphia area, at the Children's Hospital and University of Pennsylvania Albert Einstein Medical Center. You know several large level one trauma centers and teaching hospitals. So that was the start of my career and I felt, you know, very secure in terms of my my clinical expertise and my knowledge.

Speaker 2 2:51

And then I got to the point and I'll be very frank. I got to the point as, as a lot of nurses do, you know, you start to look at what's next in your career. For me it was a point of time in healthcare when, you know, we were working very short-staffed, to be quite honest, and, you know, in such a critical environment. You know, we saw all types of patients. Like I said, I was able to get, you know, lots of experience, but it was extremely stressful. I enjoyed working with my colleagues and the way that you know I say we were able to make it through is we worked as really well as a team.

Speaker 2 3:30

But I started to look and see like, well, what's the next thing? What else can I do? What else is next? You know, do I go back to school? Do I do something completely different? And you know, coming out of nursing school, there wasn't this really big push about like, oh, what else can you do? You know, here are these other things that you can do with your nursing degree, and so I hadn't known anything in detail about pharma beyond you know, pharmaceutical sales. You know that's what a lot of people on the hospital side, a lot of clinicians who've never had experience to pharma, they know pharmaceutical sales because they have that exposure to the sales reps Right, especially back back, back, back then.

Speaker 2 4:10

So I started out going to different informational fairs, job fairs, and started to bump into people who were presenting these different types of opportunities within the industry. That was, beyond you know, a sort of a pharmaceutical sales position and so my first role or foray into industry was actually in clinical data management. So I worked in clinical data management at I'm going to date myself a bit at the Smith Klein, beecham in Collegeville and you know I really I really enjoyed that because I had an opportunity to not only learn about, you know, clinical clinical trials, the industry in general, you know sort of my foot in the door and I kind of, you know, expand it from there. But if I can just take a step back a bit, you know, you know I'm this registered nurse, but I've always, even before I went into nursing school, considered myself to be a bit of a geek. I always had an affinity for, you know, playing around with computers and databases and things like that when I was younger. So I really enjoyed working in clinical data management because we got to do coding, we got to work with the database and set up the databases and do all these different types of things where I was able to use my clinical knowledge, my medical knowledge, but kind of a little had a little bit of an opportunity to play that, that that geek part, right. So, you know, working with the databases and things like that. And then from there and I went in as a consultant or a contractor, if you will. You know, and that's when I learned about, you know, contracting and things like that. And as, again, as a lot of nurses do, I worked at Smith Klein Beachum as a contractor, but I still was doing nursing as well, you know, working night shift and working day shift, because I wasn't sure if I really if this was going to be a real thing, if I really wanted to give up my nursing, you know. Ok, well, let's try this pharma thing and see if it goes.

Speaker 2 6:06

And so then, as I got into SmithKline Beach, I started to learn more about the industry and all the various parts of industry. You know, learning more about clinical trials, you know, working within clinical data management, but then being able to have an opportunity to liaise with the safety team, the safety team. And that really intrigued me because, especially at the time, you know, I felt like, you know, I wanted to go into safety because I felt like that would really give me an opportunity to really utilize my clinical skill and my way of thinking. You know, I used it when I was in data management, but, you know, working in safety, you know I could almost felt like a closer connection to be able to, you know, work towards the safety of patients you know to be, you know, having those, those, those, that adverse event reporting aspect to things. And so then I started to learn and network and see, well, what did I have to do to to go into the, the safety space? And so, again, I went into.

Speaker 2 7:05

I went to Icon, clinical Research, you know, which is a CRO that's still around, and really had an opportunity to learn the safety space and, as you probably know, working at a CRO you really get to get your hands into everything. So, you know, I was able to work in the safety space, learn about, you know, aggregate reporting, processing cases. You know I still was able to help build databases because I got pulled on to work with the clinical data group, working with the CRAs, training the CRAs, and you know all these different types of aspects of safety. So that's, you know, was the start of my career and from there I sort of just progressed forward, working at, you know, different companies and had an opportunity to work at AstraZeneca. I worked at Pfizer at the time when, you know, lipitor was being launched and Viagra was being launched. You know it was an interesting time at Pfizer.

Speaker 2 8:07

It was a very interesting time at Pfizer and I worked in the New York office. So I actually commuted up on the train from the Philadelphia area, so I commuted up on the train to Philadelphia because I thought it was a really good opportunity and it was. So I was really able to learn a lot and I I say from each, each position I've actually been able to take, you know, more and more knowledge, have more and more experience and you know, just really hone my skills in the safety space. And, to be very frank again, some of my I have two children and some of my moves were very strategic in terms of like, okay, what do I want to do next in my career. And others were very practical in terms of like, what's, what do I want to do next in my career? And others were very practical in terms of like, what's best for the family. So if you were to look at my CV, you can see that you might almost say, well, why did she go there? But it was, it was. It was kind of trying to always balance, you know, gaining more knowledge, gaining more experience, moving my career forward, but also making sure that I was in the right space in the right time for my family commitments and things like that was in the right space and the right time for my family commitments and things like that, and so that's. You know, that's sort of the clinical phase, you know, coming into my career from working as a nurse and then moving into what I call my operational phase, you know kind of getting that foundational experience working across the CROs and the different pharmaceutical companies.

Speaker 2 9:24

And then I had an opportunity to work in consulting. So I worked with the Accenture team. I was pulled into an opportunity as an extension of another team working with Accenture and so I worked on a team that was, if I can say it's out there, the first team to set up a outsourced pharmacovigilance model in Chennai, india, which then became Accenture's Pharmacovigilance Center of Excellence. So you know went, you know stayed in India for 10 months and you know Accenture had an agreement with, you know, bms or a partnership with BMS. So we went in and worked with the Accenture team and BMS to kind of create a package, the team in Chennai, and we trained up you know clinicians, doctors, nurses, people who had really a lot of them, never had done safety before and took them from. You know the very beginning of, you know, learning of like what is an AE, you know what is a single case report versus an aggregate report, was a very like step through, you know. So we, you know, at the end of that time period that 10 months, presented that package back to BMS with a team, an actual team, functional team of people who were able to process cases, do medical review, write aggregate reports. And so I was part of that team and for that particular team, you know I trained on all aspects but I was the aggregate reporting lead for that particular initiative.

Speaker 2 11:07

So you know, that sort of you know kicked off my opportunities to do consulting and I worked with Accenture for a bit, had an opportunity after Accenture, worked with Potney Life Sciences and then I went back to Accenture as a regular employee in a consulting role. So you know, like I said, for each period of my career I've taken pieces and had building blocks. So I have my clinical foundation, I have the operational foundation where I've had the hands-on experience, training on cases, you know, writing aggregate reports and doing all these different things. And then in the consulting space, you know, being able to advise and you know, on best practice and things like that. And then I came back into working with companies, after working with the consulting doing system implementations.

Speaker 2 11:57

You know process, you know improvement initiatives and you know you know different things like consultants do. And then have come back to the space where I am now sort of the, the, the, the role that I say I like to play, or the, the, the nuance that I bring is, you know, having the, being, being a nurse, understanding that the clinical aspects and the medical aspects of safety, having the operational hands-on experience to really deep dive into. You know how to do things and you know that hands-on experience I think is essential because it helps you, particularly in a consulting space, to really be able to go in and drill down to something that is on the surface layer but to really you know when you need to troubleshoot things you can say things.

Speaker 2 12:55

Your experience is you did things in the. I'm getting a. Are you still there?

Speaker 1 13:13

Yeah, yeah.

Speaker 2 13:14

Okay, you went away, for it was like spinning for a sec.

Speaker 1 13:18

That might be me, I'm good.

Speaker 2 13:20

I can hear you now. I couldn't hear you for a second. Yeah, so using that hands-on experience to inform the roles in consulting. And then now you know coming back into, you know working at pharmaceutical companies, that experience, that wealth and depth of experience you know, to be able to pull in all those different aspects, you would always surprise me that you would go into a company.

Speaker 2 14:09

There's all this, these. You know millions of dollars being spent to. You know roll out a tool or system and you know you have the business that has one. You know expectation. And then you know the IT, you know the guys that are helping to build the tool. And then a lot of times you would, you know, would sit in the room and realize that the people were talking past one another and you get to the end of the rollout, of the implementation and then the business is saying, like, well, this is not what we asked for, and IT is saying, well, this is what you asked for.

Speaker 2 14:34

So I've been oftentimes able to play the role to kind of sit in between, to help facilitate these types of implementations, whether it be a system implementation, a process implementation, to kind of help move things forward, to make sure all the pieces are connecting the way that they should be. So that's. I think that's a nice summary without being too long winded. You know, I've been around for some years. I've probably got 20, 20, some plus years of experience in cross industry and health care, some plus years of experience in, of course, industry and healthcare.

Career Development and Growth Strategies

Speaker 1 15:08

I mean, I think you have brushed past some of your career, but I agree that's amazing. You have had an amazing career. And actually, if you were to see your CV, I think it is a very impressive CV of companies that you've worked for and roles that you have done. However, I have a very interesting question for you right now which is do you think you could have had the career that you've had so far if you were starting off your PV career now?

Speaker 2 15:52

I think it would have been very different. It's interesting because I just had a conversation with someone the other day, you know, who also has extensive experience, and we were just discussing how different things are now versus back in the old days and how, you know, with the outsourcing model, you know, ensuring that you have the depth of experience to maybe to oversee your, your outsource vendors, you know, and being able to really understand the process in that level of detail. So, to answer your question, I and managers who were like very, very specific about how they wanted their narrative, you know. You know I've joked with people from you know who've been in industry for years. We'll often talk about like, yeah, you know, I remember back when it's like it was all about the narrative. You had to have this fabulous narrative, you know, and just really understanding the nuances and the things that you know.

Speaker 2 17:11

Having that hands-on experience, I think it would have been very different if I started now. I like to think that I would have strategically found a way to kind of get into the roles that would allow me to build on all the skills that I think I have with you know. Like you know, I'm not a program or an engineer by any means, but I definitely have an affinity for technology, you know. You know being able to see things strategically, like you know, these are all parts of a skillset that I think would probably help to inform this kind of role. But I think it would have been very different had I been coming into PV now, just because the model is very different from what it was 20 years ago coming into industry.

Speaker 1 17:54

Yeah, I'm really interested in the fact that you said model almost immediately this whole vendor outsourcing model. That's there. I think there's a new nuance and the new nuance is AI is going to solve everything, and the problem is that there are lots of, I'd like to say, junior people who, because of the vendor outsourcing model, are stuck. They're stuck because they can't move to another area. So if you're a case processor, you are just a case processor, and I'm talking about maybe not the massive outsourcing in a different country. I'm talking about local, you know sort of maybe smaller cro's or even local global resources as well. They're pigeonholed into such a position that they can't move on and they can't learn.

Speaker 1 19:08

And I and I I look at my career and I think, well, how would I move on now? And I think I would have found the same difficulty. Um, that there currently is and I don't know if this is going to cause a problem is, and I don't know if this is going to cause a problem in the future of PV, and I don't know if it's like I said, I don't know if it's just the rambling thoughts of a bearded guy or if it's actually a serious issue that is going to become an even bigger issue in the future.

Speaker 2 19:41

You know, I think it's something to think about.

Speaker 2 19:43

I think you bring up a good point and I think there are, you know, a couple of things, right, you know, you know saying that you have, you know, people who you know because of the new model and things like that, for whatever different reasons, whether it's outsourcing or something else who maybe feel stuck. And I think you know one of the things that I would tell people and it's not always easy to do, but feel stuck. And I think you know one of the things that I would tell people and it's not always easy to do, but you know to like just to really think about. You know, you know how they used to tell us in school like, oh you know what's your five-year plan? Where do you want to be in five years? You know it sounds very cliche a conversation. I think you know it. Really it does depend on the organization and your upward leadership, but you know, you know you have to take control of your own career as well, right? So look, you know, go to industry events, if you can go to. You know podcasts. You know things that you know things can be expensive. You know, find free things. That's what I'm always. I consider myself to be a constant learner. I'm always learning, always seeking to look at, you know, what are the new things? I like to be. I say I call it being very strategic because it's something I've always always done, you know, trying to say like, okay, well, let me stay ahead of the curve, what's the next thing coming? And so that's what I would advise to people like, okay, you have your job, you're in case processing, the job is the job and that's the paycheck. But, you know, speak to your leadership, speak to your manager, speak to your manager about like, hey, you know, I'd like to learn something, something new, something different. You know, like I said, it depends on the organization. Every organization may not have this opportunity. But, like, is there an opportunity to shadow? You still do your regular job, but you know, hey, can I go and sit with this person to see what they do to learn? Right, you have to kind of take advantage if you feel stuck. You know, look at the opportunities, you know, within your organization and then look at those opportunities outside the organization. You know companies like yours, you know, have podcasts. You know, jump into those podcasts and listen to see what's coming.

Speaker 2 21:40

You know I'm an avid reader. You know, read. You know. Now we have everything that's. You know it's, it's, it's, it's a consumption. You know world. You know you have so much stuff coming at you but you can filter out things that you think are good for you to be able to learn and provide, you know, details in your career.

Speaker 2 21:57

I give my kids the same advice. You know my son's in college and you know he's, you know, wants to go into this computer science career and you know he's he's just starting out. But I said, you know you always want to be someone who has that extra something to offer. Stay ahead of the curve, look to see where the trends are. Is there something you can go and get certified in that you think may, may, benefit you to move to the next step? So it's, it's, it's. It can be frustrating with the new model. I think it's something that we have to, you know, be cautious of. You know, having people be pigeonholed because you know it's, it's, it's. It's always more beneficial when you have people who are cross trained and can do different things. You know, in case you have someone that's out or you know whatever. You know it's all about being able to backfill and youfill and move fluidly, if you need to, through an organization, and then you also want to have people feel like they have an opportunity to learn and move up in advance.

Speaker 2 22:54

I had a manager years ago when I worked at Pfizer, and one of the things that she said to me is that, as a manager, it's my job to make sure that you're building on your career and you're developing capabilities to move you forward. As a manager, it's my job to make sure that you're building on your career and you're developing capabilities to move you forward, even if that moves you forward beyond where I am, and so I've always taken that with me Right and and and and thought about that. You know when I've had people that I've managed, or you know people that I speak to, you know it's always a thing you know it's like you to. As a leader, you want to be able to encourage people to develop and move on if they need to, and then, as an individual, you want to take responsibility for your career and look for for opportunities within your organization for for not just next roles but learning and and same thing look outside the organization you know at these different industry opportunities and be open to looking at, you know, if you're interested in case processing, you know, and you want to follow that track and you know you maybe want to go to aggregate reports, that's fine too. But also looking now you know we're in this digital world, you know looking to see what's coming forward, what kind of opportunities.

Speaker 2 24:06

One of the things that I did early on in my career, you know I had my, you know my regular case processing roles, but I would always raise my hand to volunteer for different kinds of stuff, different projects and things that might not be a part of the day-to-day, and sort of that's how I started learning about, you know, project management and things like that years ago and then went on and got my project management certification and, you know, sort of started to be able to move that forward. So that's also a skill in the toolbox that can be pulled forward. So it's lots of different things. You always have to be kind of looking and searching. It can be tiresome because there's so much stuff out here, Right. Kind of looking and searching, and it can be tiresome because there's so much stuff out here, right.

Speaker 2 24:43

And then I think you talked about the AI, was, you know? The other question is how you know, everybody thinks that the AI is going to solve all the next best things. You know it's going to be the next best thing and I think we as an industry have to be cautious, because there's always these buzzwords. I think a few years and not that there aren't good aspects, that there are, there are good opportunities, but I think a few years ago. You know, data, what was it? Big data? Was it big data?

Speaker 1 25:12

Big data yeah.

Speaker 2 25:18

Buzzword right, and everybody was like oh, how do we, what do we? How do we, what do we do? How do we, you know, data warehouse it? What do we do? And so there's definitely things to be developed and pulled from that. But you have to be careful. We have to be careful as an industry that we don't think. We think that here's a buzzword. You know, big data, ai, this that it's going to just solve everything, because we still have to be able to, to really have an understanding of what our needs are and where we're trying to go. You know, a tool is, you know, is not just going to fix something because we digitize it. We have to look at the process and look at the seed, like where we're really going and what the need is, before we just start throwing tools at things and calling it digital.

Speaker 1 25:56

So, again, looking back at your career, you've worked with big companies, small companies, huge companies, massive companies and sort of middle companies as well. You've had a career where you were a consultant. You've worked outside of industry, inside of industry, around industry. I mean it's a fantastic career. One of the things that obviously has been a big I don't know marker of your whole career has been vendors and either setting up vendors or reviewing vendors or managing vendors. Do you think the outsourcing model works, and does it work unilaterally for everyone, or does it work for specific situations?

Speaker 2 26:55

I think there's definitely a place for outsourcing, right, because it, you know it started with you know a way to, you know, extend your organization, you know, increase efficiencies, decrease costs, right, that was the biggest driver. I think there's definitely a place for outsourcing and I think there's an opportunity for everyone and maybe not to make it so absolute to say everyone, most companies I think there's an opportunity for outsourcing. I think if you look at it on like a continuum of you know companies who you know want to maintain, you know, some control and they'll outsource a little bit. You know you have to look at your organization, you have to look at how it would work for you. So you have companies who they say, you know, oh, I want to maintain some control, we'll outsource, you know, some of our older products maybe, and let you know, outsource the outsource model, work for those types of products and we'll see how things go. And then you have companies who've gone all the way to the other end of the continuum and they outsource everything.

Speaker 2 27:56

And I think you have to be cautious, because I think a company should still within reason and I guess I'm thinking like you know, big company, big resources, it may be different for a company that has, you know, five people.

Speaker 2 28:07

You know they have to outsource, you know to to, to adjust for volume and things like that. But you have to be careful, outsourcing everything, because that's when you get into a situation. Where do the people internally who have, you know, ultimate responsibility for you know, for the products, you know the process, you know, do they really know what's going on in detail? Can they get into a room and really drill down with the level of expertise that they need to solve any issues that come up? Or are they completely dependent on the outsource provider? And I think there is. There has to be a good marriage between the two. And so, you know, I definitely think there's, there's, there's the role for outsourcing, for for everyone there's an opportunity, but it's nuanced, all the control and you get into a sort of a comfort space of just overseeing things and not really being able to put your finger on the pulse of things if questions are asked. I think we have to be cautious of that.

Speaker 1 29:17

I think that's a really fair point that you brought up there about understanding and control. I think there are lots of companies that you're right give up complete control and not even understand their own process. I think there is maybe a bit of a naivety when it comes to vendor outsourcing. Sometimes that it's your process. It's not the outsourced vendor's process. It is your process that they are following and instead of managing hundreds of people, you're essentially managing one company. But it's the same thing. How you would manage those hundreds of people is the way that you manage that company. Is that a fair thing?

Speaker 2 30:10

I think so and I'd also add to just, you know, kind of stepping out of the outsource discussion and going into the process piece that you mentioned, piece that you mentioned I think it's also important for companies to really not just look at their outsourcing models and how much they're outsourcing and, you know, having control, but like looking internally and looking at their processes. You know, periodically I think I think especially some of the larger companies can get bogged down right. You know we've. You know industries changed from 20 years ago. You know regulations have changed, technology has changed and you know the core process of safety case processing is the same. But you know we've got these systems and these add-on systems and then we add on processes and you start to kind of tag on to the different processes.

Speaker 2 30:57

And I think it's good to kind of take a step back and do a process evaluation, if you will like internally. You know, and I'm not saying like, you know, run out and get consultants. Of course they, you know, they, you know they're very good at that, they can come do that and help you streamline, but really just kind of take a step out so that you don't stagnate on the process and make sure that the process makes sense, right. So you're not just, you know, having technology drive the process because, oh, I got this new technology, we're going to add this piece to the process. And then, if you really took a step back and you say like, oh, that doesn't make sense or that's overly cumbersome, I think it's good to just do that evaluation internally from time to time, and I think that's something that some companies don't always do, because you get there, you've been there for years and it works where you think it works, or even if it doesn't work, well, this is what we've always done. So we don't want to shake the boat, we don't want to go through that whole big thing. I think just kind of keeping things fresh and making sure that you are looking at the new technology. You know, not not letting allowing technology to drive everything, but looking at new technology.

Speaker 2 32:06

But I think the process is, is is a core piece that we need to stay on top of and make sure that it doesn't get overly bulky because you've added all these new systems or regular, you know, regulation changes and you have to, you know, accommodate with a system or a new process for the regulation. Make sure you can keep it as streamlined as possible, because then it becomes overly complicated for the case processors, right, and the people actually doing the work. If you have, you know all these different, you know sort of arms or avenues or nuances, and if this, then that sometimes that can't be avoided. But other times you know, when you think about, like oh, as a person who's done the work, it becomes so cumbersome that you have to now you've created all these, you know extra work practices and if, like oh, if this scenario people have, go to the cost discussion. That also will help keep costs down too, right, because if you start making things overly cumbersome, only overly bulky people have to refer to multiple documents to be able to process one case.

Speaker 2 33:13

You know it can lead to, you know Case processing time is being extended. And if you want to go into all those different avenues, so yeah, I think it's. You know, look at the outsourcing model. I think there's definitely opportunity there. But you know, be cautious because you know, as the, you know you own the process, you know not the outsource provider and you know, look at your own processes as well. I guess it's the summation of that.

Speaker 1 33:45

I think you brought up another good point with technology and I know in your recent career and potentially your current role, technology plays a big part and you maybe I'm boiling this down a little bit too much and I apologize if I'm making it over central, but you essentially were almost internally managing large-scale projects, right?

Speaker 1 34:17

um and were you disappointed with some of the outcomes, not because of the way that the project was run, necessarily, but by promises made by vendors or things that you had thought about at the beginning of the project and again, I'm guessing these are large-scale, multi-year projects and how things change from the promises at the beginning. Yes, we can do this. Yes, we can do this. Yeah, we can do this to near the end, where it's like, oh well, I don't remember us discussing this, was this in the requirements? But how? How have you dealt with all of that and do you think there's a massive change?

Speaker 1 35:04

in recent years with these large scale projects.

Navigating Project Complexity and Vendor Relationships

Speaker 2 35:14

So, yes, it's a short answer. So I've been lucky enough, so I managed large, large scale projects and I think if you go to anyone who's worked in industry, who's worked on technology projects in particular, um, uh, on a large scale, you know you've had experiences with a vendor not any particular vendor a vendor, um, where and not even saying that this is their intention, right, but where you know you go in, you you think you know you're gathering requirements and things like that, and then, intention right, but where you know you go in, you think you know you're gathering requirements and things like that, and then you get to the end and you know it's just like eh, this things changed. And there's lots of reasons for that. Sometimes some of the projects I've worked on have been you know large, not just large scale projects, but complex, right, because you have all these different inputs you have. You know large, not just large scale projects, but complex, right, because you have all these different inputs you have. You know your technology landscape within your organization. You know.

Speaker 2 36:08

So what does that look like? You have your processes that you know feed into, you know they conjoin to be a part of that ecosystem and then you have you know the regulatory impact that's coming in, and so that's in the last years I've seen is something that's coming in and so that's in the last years I've seen is something that's really been impacting the projects in particular, is, you know, really trying to? You know, have that regulatory intelligence and, you know, have your finger on the pulse of, you know, what are the regulators going to do in any particular region, and then trying to ensure that not only are you going to be compliant from a regulatory perspective and that your process is going to be able to meet those requirements, but then your technology is going to be able to work to meet those compliance requirements, initiatives that roll out from the different regulators, and they said, okay, by this date, you know you have to be able to, you know, submit these types of reports, or you know the system has to be able to do this, and so then you go to your vendor and they, you know they're also trying to stay on top of the you know, the regulatory requirements that are coming from the agencies, right, and so you know, there's times where I, you know, you know, having having done this, and you have to kind of step back, and you know you could sit and be mad and be like, oh, they told us they were going to do this no-transcript, frustrating part. Like you know, you got the regulators and we're, all you know, trying to make sure we're compliant. That's the big thing. But technology doesn't shift. Technology of a certain size in particular, doesn't shift on a dime. So the vendors who are, you know, saying, you know we were disappointed because, oh yeah, they said this was going to be, you know, ready by this. You know we were disappointed because, oh yeah, they said this was going to be ready by this first quarter this year and oh, they didn't have it. But then when you sit down and you have those conversations and you know, you realize they're trying to Shift their system to meet the requirements, but then the requirements aren't fully finalized by the agency. So it's you know. So it's like you know this whole, this whole cycle.

Speaker 2 38:25

So, um, you know, like I said, the short answer is yes, like, yes, I've run large projects. You know where we've gotten to the end. Or we've worked with a vendor. We said like, ah, you know what, that's not really, um, what we promised, and we have all worked with different vendors. And you start to know, you know, okay, who you, who you would like to work with on certain projects, and I've been lucky enough to work with some really good vendors who you know. You work with a vendor on initiative and you realize, like, ok, this is a good partner and you can move you know, move that partner forward that has the capabilities to do these different types of things, and so that's something that you can keep in your, in your toolbox as someone who's managing these large projects, in your toolbox, as someone who's managing these large projects Right, and you know who your go-to vendors are when you need to do certain things and who you know in the past has delivered accurately and on point.

Speaker 2 39:12

And and you know, and you know to contract if you will, you know who's who's who's done, what they say they're going to do, right, and so I think it's it's, it's you know. You know I give, I give grace to the vendor sometimes, because I realize it's not simple, but also you have to also hold them accountable to. You have to have to know and this is where it comes where you know knowing up front, you know gathering good requirements, knowing your process and you know making sure your process is good, right, we, you know we, we as the owners of the process, have some, have some responsibility to make sure you know we're, we're, what we're asking, you know, makes makes sense, and that there's a discussion between you know, the vendors, the process owners. You know, and in terms of you know, having that conversation of like, well, this is what we want to do, can you do it? And then some some onus on the vendors to say, not just to say, because they want the check, oh, yeah, yeah, we can do it. You know, to get the contract, to get the work.

Speaker 2 40:11

You know, having a realistic conversation I think is is, from my perspective, perspective is appreciated to like let's sit down and really have a conversation Like this is what we're trying to do. Here's our process, here's our current technology landscape. You know, can you help us do X, Y and Z? And you know, you know, if we move forward with this project, making sure that you have the right people that's also key right On these different large-scale projects. On the front end, from the business side, you know, making sure you have the right SMEs and making sure all the key people are in the room. You know, making sure the questions are being asked and making sure you're gathering good requirements, and you'll gather good requirements if you have good people. If you have not good people, but the right people, the right SMEs in the room. So then when you get downstream, you know you're giving the vendors something that you can, that they can, that they can also, that they can also work with. But it has to be a good partnership there.

Speaker 1 41:11

I have one more question before we get to our last question. So, penelope, the question but it came up in what you were just saying there, which is about requirements and having the right people in the room Is there and, sorry, it goes a bit left as well In recent years, I would say more and more in recent years, more and more in recent years there is a control of where you can get either your vendor from or how you run a project, because, especially with technology, the companies, what they'll do is the budget for that is held within the IT group. What they'll do is the budget for that is held within the IT group. Now, what that means is that if I'm talking about you know from, if you wanted to bring a new vendor in, you can't because for that specific experience that you're talking about, say it's just one person. It might just be one person that you want to bring in, but because they're not on that approved vendor list.

Speaker 1 42:30

you have to go through whoever it is, and it might be a big consultancy firm. It might be someone who are a big finance consultancy firm and actually have nothing to do with life sciences. And then also on top of that, you've got this pressure from it which is saying well, we don't care that you want to potentially go to another software vendor or another uh process vendor or something, because they're not on our approved list. How do you deal with that?

Speaker 2 43:11

So you know, disclaimer, it ultimately depends on the company and the environment and if they're open.

Speaker 2 43:14

But you know, one of the ways to deal with that is and one of the ways I dealt with it in the companies I've worked with and we're lucky enough to have the structures you know set up where we could have a relationship with IT. So you know, like you're saying, you have these projects that are funded. You know that you know of a certain amount that are funded through IT and maybe a portion is, you know, funded through PV. You know, however, however the combination goes, you know however it goes, you know where it's fully IT funded or it's partially PV funded or fully PV funded, depending on the project. I think in those instances, like I said, it depends on the company if they're open. But you know, if there's a vendor that you want to go to that's not on the approved list and you've worked with vendors before and have had this scenario happen that you know, we know we worked with them before, we've had challenges, you know, multiple times things didn't go well, they didn't deliver, but yet they're still on the list and so we're still being told we have to work with this particular person. I think what we did was we made a business case to be able to work with a particular vendor and in our case, this vendor had a particular, you know, skillset nuance. It was a small firm and you know, we went and because, you know, we had a relationship with IT, we got the support of our leadership. We started with, you know, with our internal PV leadership, to say like, hey, this is what we want to do. In our case it was something that was, you know, being driven by new regulations that were coming in, so we had a little bit of, you know, extra oomph that you know, the vendors that we had worked with previously, you know, didn't necessarily have the extensive or deep bench in knowledge and skillset that they would have needed to have to address this particular need that we were trying to go to. So that was one instance and we made the case. We said, hey, listen, this is the experience we've had before with this vendor, this is what we would need them to do. Do we think that they're capable of doing this? They can do, probably, a portion of that work. But here's this other company that has this experience. They have this deep bench, they've done this kind of work. They know the nuances of this. This is what we're trying to do.

Speaker 2 45:24

And then you know, and again, it all it also always comes down to cost. So you know, and you know, looking at the cost of, of of, you know of, you know the different, the different vendors, and this is where it helps when you have that experience. So when you see, you know a proposal, come through, if you have the level of experience you know, you can kind of call BS. If somebody is telling you, ah, we're going to do this for you know these little bit of dollars and it's going to be wonderful, it's going to be fabulous, you kind of have to know where to go and to look to say, hmm, I've worked with you before, I know how you, how you, do business and I know that's not really going to cost what you're saying. It's going to cost if you're going to really do it the right way. And so you know being able to ask those questions.

Speaker 2 46:10

And then you know, when you're trying to have an argument to get it, bring a new vendor on board, putting that into your business case to support, like, yeah, you know these guys are here and they're on the master list, and you know, if you have a good relationship with IT, you can say like, hey, you able to say we would like to go with these vendors, and so there's different ways that you can work around it, and at the end of the day, they may just have a model that they just aren't. You know. A company may say we just this is who we're going to have to use, and you have to work with these people. But I've seen that a lot as well. You know where, you know you're being pushed to go to a particular vendor, even if they don't have the expertise, but they're on that master list, and so that's one of the ways that I would go about trying to do to see if we could bring a new vendor on board. It may work, it may not work, but it's always worth to try to be able to build up that, to build up that case.

Speaker 2 47:22

And those are some of the things that you can utilize to try to be able to build up that case. And those are some of the things that you can utilize to try to push your point forward. And having those partnerships in IT relationship building is important so that when you need to go and you need to talk to someone. You have a person that you can talk to, who is gonna listen right, who you at least have a relationship to say. Let me explain my point. And then support from your leadership. You know I had excellent leadership, you know in previous roles who on the PV side who was always open to to, to listen and then move that fight forward if we, if we needed to, to the higher levels.

Speaker 1 47:57

So yeah, I think that's. That's a really good point. It's been a fascinating conversation, but we're coming to the end of the podcast and you know the podcast is called Innovation and the Future of Pharmacovigilance.

Speaker 2 48:14

Yeah.

Speaker 1 48:14

So Sabra what's next in PV.

Improving Operational Efficiency With Digital Tools

Speaker 2 48:21

I think the world is our oyster right. I think right now you're hearing AI is the buzzword, digital is the buzzword To help make PV, case processing, reporting, analytics, you know risk management, all of those things you know more efficient and cost effective. One of the things I think and I guess I would end with this is to look towards the future, to, to, to look towards the future. I think companies really should take a step back and kind of look at their organizations and look to see kind of, you know, do do almost an assessment of where the needs really are, where the efficiencies can be gained, um, where there are opportunities, um, to make improvements with, you know, digital technology, not just just AI and not just sort of, you know, kind of going out to try to find AI tools because it looks cool and it looks, you know, it's hot and sexy, and just kind of trying to put that over top of you know a PV organization. Put that over top of you know, a PV organization.

Speaker 2 49:46

I think you know a lot of companies you know should really take the time to, you know, outside of the day-to-day, if they have the people and the resources to really look at the processes, make sure the foundation is sound and do that assessment. Understand you know where there are some really true needs for operational efficiency, cost savings, streamlining, and how the digital tools and technology can help with that. And then also being aware I mean there's new stuff coming out all the time. The vendors, people are creating their own tools and customizations and things like that. But you know, having people within the organization that keep their pulse on what technologies are out there and how they would be a good fit for their particular organization, because you know what works for company A and company B may not be a good fit for company C.

Speaker 1 50:39

So Sabra, it's been an amazing conversation with you. I thank you very much for joining me today thank you so much for having me indy.