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Pharmacovigilance Glossary

QPPV (Qualified Person for Pharmacovigilance)

Every hospital has one attending physician who can always be reached, even at 3am. Every marketing authorization holder in the EU needs the same thing for drug safety: one specific person, always reachable.

What is it?

The QPPV is the single, named individual an MAH must appoint to hold overall responsibility for its pharmacovigilance system in the EU. It's not a department or a rotating duty roster, it's one accountable person whose name and contact details are on file with regulators at all times.

Behind the scenes, the QPPV usually has a whole team supporting them, but the accountability itself doesn't get distributed. When a regulator needs a single point of contact for a serious safety concern, the QPPV is who they call.

What actually makes someone a QPPV

Hover each requirement to see what it means in practice.

Hover a pin to see what it requires
Qualified Person for Pharmacovigilance
On record with regulators
One Named Person
Not a shared committee role. A specific, identifiable individual is on record, with a named deputy for when they're unavailable.
EU/EEA Based
Must reside and operate within the EU or EEA, regardless of where the MAH itself is headquartered.
Reachable 24/7
Contactable around the clock, every day of the year, for any safety issue serious enough to need escalation.

Common Misconceptions

Myth

"QPPV sounds like a job title. Couldn't a few different people rotate through it?"

Truth

It has to be one specific, named individual formally on record, not an interchangeable role. There's usually a named deputy for coverage, but the primary accountability stays with one identified person.

Explore related terms

MAH (Marketing Authorisation Holder)
PSMF (Pharmacovigilance System Master File)
RMP (Risk Management Plan)