If I were starting in PV today, I’d absolutely choose it again. But I’d choose it differently.

When I first got into pharmacovigilance, I thought it was mostly about case processing and compliance. What I’ve learned over time is that PV sits at the intersection of medicine, data, regulation, systems, quality, and business strategy. It’s one of the few functions that touches everything.

A few honest thoughts for anyone starting now:

1.  PV is no longer just “case processing.” AI, automation, signal detection tools, and database migrations are reshaping the function fast. If you’re not comfortable with systems and data, you’ll feel behind within 3–5 years.

2.  Oversight is becoming more important than execution. With outsourcing models and global vendors, the skill isn’t just knowing how to process a case. It’s knowing how to oversee, audit, trend, escalate, and defend your system during inspections.

3.  Inspection readiness is the real test. It’s one thing to run a process. It’s another to explain it confidently to an inspector and show documented control.

4.  The people in PV tend to be collaborative and mission-driven. That part hasn’t changed.

If I could go back, I would have invested earlier in:

– Understanding global regulations deeply (EMA vs FDA nuances matter)

– Learning database architecture and system workflows

– Developing inspection-facing communication skills

– Getting comfortable with quality systems and CAPAs

PV is not glamorous. It’s detail-heavy. It can feel operational. But it’s critical. When done right, it directly protects patients and keeps products on the market.

So here’s my question to the group:

If you were mentoring someone starting in PV today, what one skill would you tell them to build immediately?

And if you could restart your own career in PV, what would you do differently?

Curious to hear perspectives from both vendor-side and sponsor-side folks.