Every marketing authorisation holder in the EU needs a qualified person responsible for pharmacovigilance who is based in the EU and available on a continuous basis. The QPPV needs sufficient authority, access to safety information and visibility across the pharmacovigilance system to fulfil the role.
Appointing an external QPPV does not transfer the MAH's legal accountability. A workable model must define how the QPPV, deputy, MAH leadership, internal functions, local contacts and vendors exchange information and make safety decisions.
What is the EU QPPV responsible for?
The EU QPPV oversees the establishment and maintenance of the MAH's pharmacovigilance system. The role is system-wide and cannot be reduced to acting as an emergency regulatory contact.
The QPPV needs appropriate oversight of:
- the safety profile and benefit-risk balance of authorised products;
- the collection, evaluation and submission of ICSRs;
- signal management and safety issue escalation;
- PSUR/PBRER and other aggregate reporting;
- Risk Management Plans and risk-minimisation activities;
- the content and maintenance of the PSMF;
- pharmacovigilance agreements and outsourced activities;
- compliance metrics, deviations and CAPAs;
- audit and inspection findings;
- business continuity and out-of-hours safety escalation;
- relevant changes to products, territories, systems, vendors and organisations.
The QPPV must be able to influence the pharmacovigilance system and obtain the information needed to evaluate safety and compliance. This authority should be reflected in governance documents, contracts, escalation procedures and management access.
View EMA Good Pharmacovigilance Practices
EU QPPV, deputy and local contact: different roles
| Role | Primary purpose | Key operating requirement |
|---|---|---|
| EU QPPV | System-level oversight of the MAH's EU pharmacovigilance system | Continuous availability, authority, access to relevant safety information and oversight of the PSMF |
| Deputy or back-up QPPV | Maintain effective coverage when the QPPV is unavailable and support continuity | Defined delegation, access, training, handover and escalation arrangements |
| Local pharmacovigilance contact | Meet applicable national contact, language or local-process requirements | Responsibilities defined for the specific territory and connected to the central PV system |
| Regulatory contact point | Enable EMA to contact the MAH directly on relevant non-procedural regulatory matters | Maintained in accordance with the applicable EMA registration process |
The exact local-contact model varies by territory. It should be based on current national requirements rather than a standard assumption that every country requires the same role.
What remains with the MAH?
The MAH remains responsible for operating a compliant pharmacovigilance system, including activities performed by service providers.
The MAH should therefore retain clear ownership of:
- the decision to appoint and resource the QPPV model;
- access for the QPPV to senior management and relevant functions;
- approval of the pharmacovigilance operating model;
- vendor selection, contracting and oversight;
- timely escalation of product, clinical, regulatory and organisational changes;
- implementation of QPPV recommendations and documented resolution of disagreements;
- quality-system governance, including deviations, CAPAs, audits and management review;
- provision of complete and timely information to the QPPV.
The service agreement should distinguish between work performed by the provider and decisions or actions that remain with the MAH.
Information the QPPV needs from the organisation
A QPPV can only provide meaningful oversight when information reaches the role early enough to influence decisions.
The operating model should define notification of:
- new products, indications, territories and authorisation procedures;
- clinical-trial and development-safety changes relevant to authorised products;
- signals, emerging safety issues and urgent authority requests;
- changes to reference safety information and product information;
- planned regulatory submissions and data lock points;
- vendor, database, process and system changes;
- mergers, acquisitions, divestments and licence transfers;
- audits, inspections, significant deviations and CAPAs;
- changes to local contacts, affiliates and safety-data exchange agreements.
These interfaces should be documented in SOPs, agreements, governance calendars and escalation pathways.
QPPV onboarding: what should be ready?
| Area | Information or decision needed |
|---|---|
| Product portfolio | Authorisation status, territories, lifecycle stage, safety profile and upcoming milestones |
| PV system | Current PSMF, SOPs, organisation chart, compliance metrics and governance structure |
| Safety operations | Case sources, database, reporting model, literature, reconciliation and medical review |
| Benefit-risk management | Signals, RMPs, PSURs, safety concerns and open regulatory commitments |
| Vendors and partners | Contracts, PV agreements, delegated activities, oversight evidence and escalation contacts |
| Local coverage | Current national requirements, appointed contacts and language arrangements |
| Business continuity | Deputy coverage, out-of-hours process, system access and urgent-contact testing |
| Quality and inspection history | Audits, inspections, deviations, CAPAs and unresolved risks |
The onboarding plan should include transfer of knowledge, system access, document review, open-action tracking and a formal confirmation that the QPPV can perform the role.
How to assess a QPPV service model
Before appointing a provider, confirm:
- who will serve as the named QPPV and deputy;
- where they are based and how continuous availability is maintained;
- how the QPPV accesses the safety database, PSMF and source information;
- what decisions require QPPV review or notification;
- how urgent issues are escalated and tested;
- how local contacts are selected, trained and overseen;
- how conflicts, recommendations and MAH decisions are documented;
- how the provider supports inspections, audits and authority requests;
- what happens when the QPPV, MAH, product portfolio or service scope changes.
Read how to choose an EU QPPV provider
How NextPV can support the QPPV operating model
NextPV can provide or support:
- named EU QPPV and deputy coverage;
- assessment and design of the QPPV governance model;
- QPPV onboarding and system familiarisation;
- PSMF oversight and maintenance support;
- local pharmacovigilance contact coordination where required;
- safety issue and regulatory-request escalation;
- oversight of vendors and pharmacovigilance agreements;
- compliance review, management reporting and inspection preparation;
- regulatory intelligence impact assessment;
- transition support when the QPPV or provider changes.
We can work as part of a complete outsourced system or alongside the MAH's internal PV team and existing providers.
Related NextPV guidance
- How to choose an EU QPPV provider
- EU Market Entry pharmacovigilance
- PV systems, PSMF and quality management
- EudraVigilance and XEVMPD responsibilities
- All NextPV pharmacovigilance services
Discuss your QPPV model
Share your authorisation status, territories, current PV structure and expected scope. We will help map the QPPV, deputy, local-contact and MAH responsibilities before implementation or transition.