Pharmacovigilance Operating Model Risk Assessment

If you’re responsible for pharmacovigilance, you need to know whether your operating model actually protects you, even when critical parts sit outside your direct control.

It’s a question that keeps many PV leaders up at night. You might have a capable team managing day-to-day activities, but what happens when an inspector arrives? Or when your CRO suddenly restructures? Or when regulatory requirements shift and you need to demonstrate oversight you thought you had? The cracks in an operating model don’t always show until you’re under pressure.

The Pharmacovigilance Operating Model Risk Assessment is designed to give you clarity before that pressure hits. We ask 12 targeted questions across three critical areas: governance structures, inspection readiness, and resilience under change. These aren’t surface-level questions about whether you have the right documents in place. They dig into whether your model actually works when tested, whether you have real visibility, genuine control, and the ability to respond when things don’t go according to plan.

We’ve weighted the higher-risk areas more heavily because not all vulnerabilities carry the same consequences. A gap in your vendor oversight framework, for instance, poses a very different risk than a gap in your training records. The scoring reflects that reality.

At the end, you’ll see exactly where your risk exposure sits. More importantly, you’ll get practical guidance on whether an in-house, outsourced, or hybrid model makes sense for your needs right now, not based on industry trends or what others are doing, but based on your actual capacity, risk tolerance, and strategic priorities.

Take the assessment now and get your results in under 10 minutes. You’ll know where you stand and what to prioritize next.