Industry: regulatory affairs or pharmacovigilance?

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octobus

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Does anyone know which department is more suitable for pharmDs, generally speaking?

I'm already working in the industry but interested in switching to either of the two departments above. At my current company, PV does seem to be more popular than RA, but I'm not sure if that's the norm.

I want a position where I'll be able to use and practice clinical knowledge somewhat. It'll also be nice if there's a clear career progression route for the position as well. Butttt at the same, dont want to be a workaholic- work/life balance is also important to me.

Please kindly advise!

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I am not sure about pharmacovigilance, but if you get a job in regulatory you will be set. They can be very lucrative careers. As for work life balance, anything beats working in a retail pharmacy. I worked as a tech and I hated it. It is worse as a pharmacist.Good luck.
 
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What are you currently doing?

Clinical Operations.

If I go to RA, I'll be repsonsible for submissions related to clincial trials.
If PV, I'll be handling cases from clinical trials.

My boss said my experience in Clinical Operations will not be wasted. At least not if I switch within my current company.
 
Clinical Operations.

If I go to RA, I'll be repsonsible for submissions related to clincial trials.
If PV, I'll be handling cases from clinical trials.

My boss said my experience in Clinical Operations will not be wasted. At least not if I switch within my current company.

At my company PV is definitely a lot more clinical than RA. That said, the most helpful RA representatives understand the relevant clinical issues, so it could be potentially easier to distinguish yourself in RA. Both are solid options. Personally, I don't enjoy RA enough to do it full time.
 
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If I were you, I would arrange one on two stretch projects before making the switch - ideally one in each department under the manager or director you’ll report to, for a couple reasons:

1. You’ll have firsthand experience that someone else’s description can’t provide

2. You’ll glean some information on the people you’re working with, which is just as important, if not more so than the subject matter

Personally, I think RA provides more of a moat career security-wise as there are so many country-specific regulations to deal with.
 
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Spent a summer in each department...boring affff
 
Both are suitable for PharmDs. Pharmacovigilance, or PV, was (and still is in some companies) a division of RA that's become more its own separate niche discipline. That said, the 2 departments still work together a lot.

Here are some observations:

- Both areas are quite broad and have several sub-areas that people specialize in. For example, in PV there is case processing, medical assessment, compliance & training, aggregate reporting, clinical study safety operations, signal detection/risk-benefit management, safety data management...and then you have might see some extra roles like project management, strategy, and of course people who are focused on the leadership/people management track (but they have usually developed through the other areas). Another way to think of it is there are 2 main areas - operational vs. strategic, or individual contributor (functional expert) vs line management. There is a somewhat of a glass ceiling in PV - MDs tend to be favored for the highest paying and lead decision making positions in clinical/medical areas. Sometimes that extends to overall leadership too - MDs just inherently carry more weight when dealing with medical monitors, and clinical groups.

- Similarly, RA has operational vs strategic roles. What you do within RA can vary greatly - Labeling, Strategy/Program Management, CMC, Submissions, etc. I think you mentioned you'd be doing submissions. This role is pretty operational and might get old fast, but I guess it depends on what you make of your situation that determines whether it's pigeon-hole or a foot in the door to a great opportunity. It's the same for PV. People get pigeon-holed into case processing for 20 years without ever moving into other areas.

- Both RA and PV can be high visibility, lots of pressure, and high stress. But it's a different kind of stress from retail pharmacy.

- Because having a MD doesn't make a difference in RA, I guess you could say that a PharmD can go very far in RA. In general, I've seen PharmDs in RA go through promotions faster than PV.

- There's currently a decent demand for both, but RA might be more. With people exploring automation, some operational roles in PV may be replaced by automation within the next 10 years (I hear it's already started in some large companies).

- The learning curve for both are steep, and the first year or few can be very tedious work. I think it might be worse for RA than PV. But, you have to do the tedious work to build the foundation for later. Medical Information, on the other hand, tends to be more "relate-able" to PharmDs and less of a learning curve. Not much in Pharmacy school or retail/hospital really translates to PV or RA though. Med Info experience translates to PV/RA in limited amounts. This steep learning curve is exactly why experienced PV or RA professionals are valued though.
 
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Clinical Operations.

If I go to RA, I'll be repsonsible for submissions related to clincial trials.
If PV, I'll be handling cases from clinical trials.

My boss said my experience in Clinical Operations will not be wasted. At least not if I switch within my current company.

What is your exact role in clinical operations? CRA? Your role within the same branch of an industry can also make a huge difference.

I am in PV for 4 years now, and I have ventured from CP to many other categories including AR and Submissions. Also, weather you work for a Big Pharma or a CRO makes a lot of difference too. You can PM me:)
 
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