The QPPV — Role, Legal Status, and Personal Accountability

The QPPV — Qualified Person for Pharmacovigilance — is an EU legal requirement: every marketing authorisation holder operating in the EU/EEA must have one specific, named individual, resident and operating within the EU/EEA, personally accountable for the company’s pharmacovigilance system. This isn’t a job title assigned to whoever happens to run the PV department — it’s a defined legal role with specific, non-delegable accountability.

That accountability covers several concrete responsibilities. The QPPV has overall oversight of the PV system’s functioning — not personally processing every case, but ensuring the system that processes cases is actually working. They’re responsible for the PSMF being accurate and genuinely current, which is exactly why Lesson 11.5’s coverage of keeping the PSMF and operational reality in sync matters so directly to this role. They’re responsible for ensuring the PV system is adequately resourced — staffed, trained, and equipped to do the work the regulatory obligations actually require. And they serve as the primary point of contact for regulatory authorities on pharmacovigilance matters, meaning when an inspector has a question about the system, the QPPV is who answers it.

Because this accountability can never have a gap — not even for a planned vacation or an unexpected absence — EU requirements mandate a deputy QPPV arrangement, a named backup empowered to act with full QPPV authority when the primary QPPV is unavailable. A company without a functioning deputy arrangement has a genuine compliance gap the moment the QPPV is unreachable, regardless of how well everything else in the PV system is running.

The reason this role is designed around personal, not organisational, accountability is worth sitting with. Diffusing responsibility for PV compliance across a department, with no single individual whose name is on the line, has historically made it easier for gaps to persist — everyone assumes someone else is watching. Naming one accountable person, whose personal professional standing depends on the system actually working, closes that gap by design. It also means the QPPV role carries genuine personal risk, which is part of why this module treats it with the weight it does rather than as one more organisational chart box.