QPPV
Qualified Person Responsible for Pharmacovigilance
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The QPPV is a named, appropriately qualified individual — required in the EU — with personal responsibility for the establishment and maintenance of the marketing authorization holder's pharmacovigilance system. The QPPV has oversight of the safety profiles of the company's products and of any emerging safety concerns, must be permanently and continuously available, and resides and operates in the EU/EEA. The role is the accountable human point of contact for the authorities on pharmacovigilance matters.
The QPPV's existence and contact details are recorded in the pharmacovigilance system master file (PSMF), and the person must have sufficient authority to influence the quality and safety systems — the role is one of substantive accountability, not a mailbox.
National competent authorities may additionally require a national-level contact person for pharmacovigilance, distinct from the EU QPPV.
- —Named individual personally accountable for the PV system (EU requirement)
- —Resides/operates in the EU/EEA; continuously available
- —Oversight of product safety profiles and emerging concerns
- —Identified in the PSMF with defined authority
EU pharmacovigilance legislation QPPV requirement (Directive 2001/83/EC); GVP Module I on pharmacovigilance systems.
Frequently asked questions
What does QPPV stand for?
QPPV stands for Qualified Person Responsible for Pharmacovigilance.
What is QPPV?
The QPPV is a named, appropriately qualified individual — required in the EU — with personal responsibility for the establishment and maintenance of the marketing authorization holder's pharmacovigilance system. The QPPV has oversight of the safety profiles of the company's products and of any emerging safety concerns, must be permanently and continuously available, and resides and operates in the EU/EEA. The role is the accountable human point of contact for the authorities on pharmacovigilance matters.
Which regulations cover QPPV?
EU pharmacovigilance legislation QPPV requirement (Directive 2001/83/EC); GVP Module I on pharmacovigilance systems.