#48 Building a career in pharmacovigilance – Myriam Salem & Francesco Salvo

So you work in two different settings, right? A regulatory authority, Miriam, and academia and research, Francesco.

Right.

So one of our listeners, Alex, a pharmacy student in the US, asks, how different does pharmacovigilance look depending on where you sit? Are you working on different types of questions or different timelines? Are you facing different pressures? In other words, what does your everyday job look like? Francesco, why don't you start?

For me, so it's the same field, of course, but we answer two different philosophical, I would say, basic questions.

From academia, I'm interested of understanding or improve safety science.

And I think that from a regulatory point of view, you have to answer to the question, is this drug safe now? And need I to do some actions in order to reduce some risk? So from an academic point of view, my work is, I would say, more hypothesis driven, more innovation driven.

I need to develop methods.

I have long timelines and probably I have just one pressure that is more to publish.

my findings.

From a regulatory point of view, it's a bit different.

I think that there is sometimes you have urgency to answer to questions.

You speak more about population safety level.

You need to have, I would say, a real-time decision, a mandate that is very public and legal, and you work in a more structured process or framework.

But Miriam, please complete it.

Thanks, Francisco.

I think that, and this is my personal point of view on this aspect, I think that, yes, you're right, the regulatory has to abide by certain regulations, but there is also some type of collaboration, a lot of collaboration with academia, where you also rely on these research that are happening externally to see how you can manage these risks.

So, for example, I have worked in the opioid setting because in Canada we were facing a major epidemic of opioids.

So a lot of people had, you know, all of these dependent syndrome and we did collaborate a lot.

And I think that you need that type of collaboration across the fields ultimately to ensure the best balance of benefit, harm, uncertainty, and you want the patients, you want the population to be safe.

So I think that collaboration is extremely important.

So you definitely need both types of organizations for pharmacovigilance to thrive as a scientific discipline and you need many other actors in reality.

And we'll cover some of those later.

But Alex, our listener had another question.

So do you think as a trainee that you should also experience both environments early in your career or...

Is it more practical or advisable to pick one track and go deep and specialize in that, Miriam? You know, Federica, I