Qualified Person for Pharmacovigilance (QPPV)

EU and UK legislation require a Qualified Person for Pharmacovigilance with real, documented oversight of the safety system — and inspectors probe hard to confirm the role is substantive rather than nominal. PharmExpert provides experienced QPPV and deputy QPPV services, local/national PV contacts, and full maintenance of the Pharmacovigilance System Master File.

Our QPPVs deliver genuine oversight: they understand the system they are accountable for, monitor its performance through defined metrics, and have the standing and escalation routes to act when something is wrong. A QPPV who is merely a name on a form is a liability, and that is not what we provide.

We create and maintain the PSMF as the accurate, current description of your PV system that regulators expect, and we provide the local and national contact persons individual markets require — giving you a coherent, compliant oversight structure across geographies.

Oversight extends to partners and vendors, with documented governance and inspection readiness throughout. We also provide interim and transition QPPV coverage to maintain compliance during organizational change, so there is never a gap in accountable oversight.