QPPV and LPPV Roles in 2026: Responsibilities
- 10-12-2024
- Posted by: Kanila Akhmetova
- Category: Uncategorized
Updated 15 July 2026.
The qualified person responsible for pharmacovigilance (QPPV) and the local pharmacovigilance contact person (LPPV/LCPPV) provide governance and local execution for a medicinal-product safety system. Titles, qualifications, location requirements and statutory duties vary by jurisdiction; an EU role description should not be copied unchanged into an EAEU or national system.
QPPV responsibilities
The QPPV oversees the marketing authorisation holder’s pharmacovigilance system and needs sufficient authority, access to information and influence over the quality system and product safety profile. In the EU, the MAH must have an appropriately qualified EU QPPV permanently and continuously at its disposal, supported by documented back-up arrangements.
- oversight of system performance and regulatory compliance;
- awareness of emerging signals, benefit–risk changes and risk-minimisation measures;
- oversight of ICSR, PSUR/PBRER, RMP and authority-response timelines;
- involvement in PSMF governance, deviations, CAPA, audits and inspections;
- continuous availability and effective, documented deputisation.
Local pharmacovigilance contact responsibilities
An LPPV or LCPPV represents the system nationally where required by law or the company’s operating model. The role liaises with the local authority, manages local language and timelines, monitors national sources and routes safety information into the global system. Appointment of a local contact generally does not transfer the MAH’s or QPPV’s ultimate responsibility.
QPPV versus LPPV
| Aspect | QPPV | LPPV/LCPPV |
|---|---|---|
| Level | System oversight within the applicable jurisdiction | National operational coordination |
| Focus | Governance, risk and compliance | Local cases, timelines, language and authority contact |
| Authority | Must enable influence over the PV system | Defined by local law and agreements |
| Back-up | Formal and testable | According to local rules and procedures |
How to allocate responsibilities
- Map countries, products and applicable requirements.
- Approve a RACI matrix for ICSRs, literature, signals, RMPs, aggregate reports and authority requests.
- Define availability, deputisation, escalation and timelines in SOPs and agreements.
- Give the QPPV access to databases, metrics, audit results, contracts and safety decisions.
- Regularly test contact details, training and end-to-end interaction using practical scenarios.
Common compliance risks
- nominal appointment without authority or access to data;
- unclear boundaries between global and local teams;
- ineffective back-up arrangements or outdated contacts;
- missed local literature or digital-channel reports;
- misaligned timelines and duplicate partner submissions.
Official resources
- EMA Good Pharmacovigilance Practices (GVP).
- EMA pharmacovigilance system questions and answers.
- EEC: amendments to EAEU Good Pharmacovigilance Practice.
PharmExpert supports QPPV/LPPV operating models, RACI matrices, back-up procedures, safety agreements and inspection-readiness packages.
This article is for general information. Confirm the precise requirements against current legislation in each relevant jurisdiction.