Every company marketing medicines in the EU must have one person permanently responsible for the safety of those products: the Qualified Person for Pharmacovigilance. It is one of the most consequential appointments a marketing authorisation holder makes.
The QPPV role is mandated by Directive 2001/83/EC and Regulation (EU) No 726/2004, with operational detail set out in GVP Module I. The marketing authorisation holder (MAH) must have a QPPV permanently and continuously at its disposal.
Residence and availability
The QPPV must reside and operate in the EU/EEA and be available 24 hours a day, 7 days a week to both authorities and the company. The role can be contracted rather than held by an employee, but the responsibility is personal and cannot be delegated away.
Core responsibilities
- Establishing and maintaining the MAH’s pharmacovigilance system.
- Maintaining an overview of the safety profile and any emerging concerns across all the company’s products.
- Acting as the single EU contact point for regulators, including a 24-hour point of contact.
- Overseeing signal detection, PSUR/PBRER preparation, risk management plans and ICSR reporting.
The QPPV and the PSMF
The QPPV must ensure the Pharmacovigilance System Master File (PSMF) accurately reflects the PV system at all times. The PSMF must be located within the EU/EEA — either where the MAH’s main PV activities take place or where the QPPV operates — and the QPPV’s details are recorded in the PSMF and the EU Article 57 database.
Don’t forget the local level: Greece
Alongside the EU QPPV, Greece requires MAHs to appoint a Local Pharmacovigilance Contact Person to liaise with EOF. This person must be resident in Greece, hold a relevant science degree, have at least two years’ pharmacovigilance experience, be independent of promotional activities, and communicate with EOF in Greek. Many other EEA countries impose their own local-contact requirements too.
How PQRA helps
PQRA provides QPPV and local safety-officer support, PSMF authoring and maintenance, and full pharmacovigilance system set-up — so your safety obligations are covered at both EU and Greek level.
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