EU-QPPV/LPPV/RPV

EU-QPPV & LPPV/RPV

EU-QPPV & LPPV/RPV

EU-QPPV & Local Pharmacovigilance Responsible Person (LPPV/RPV)

Secure Your Pharmacovigilance System Across France and Europe

Oversight of a compliant pharmacovigilance system represents a major strategic challenge for Marketing Authorization Holders (MAHs), pharmaceutical companies, and Life Sciences organizations operating in Europe.

Within a regulatory environment governed by European pharmacovigilance requirements (GVP) and health authority expectations (EMA, ANSM), the roles of the EU-QPPV and the French Local Pharmacovigilance Responsible Person (LPPV/RPV) are central to healthcare product safety governance.

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the implementation, oversight, and optimization of European and local pharmacovigilance systems.

Our objective: to ensure the compliance of your organization, secure your regulatory obligations, and maintain a robust and inspection-ready pharmacovigilance governance model.

Regulatory Expertise Supporting Your Safety Oversight Activities

Our teams have extensive expertise in EU-QPPV and French Local PV Responsible Person activities, with strong knowledge of:
  • EMA and ANSM requirements
  • Good Pharmacovigilance Practices (GVP)
  • French MAH local obligations
  • international and multi-affiliate environments


We support organizations with:

  • EU-QPPV or Local PV Responsible Person functions
  • oversight of PV systems
  • support to Responsible Pharmacists
  • organizational structuring, mergers, and transformation projects involving pharmacovigilance systems


An approach combining regulatory expertise, operational excellence, and strategic vision.
Ensure Compliance of Your European Pharmacovigilance System

The EU-QPPV role requires continuous oversight of the European pharmacovigilance system and associated safety activities.

Atessia Vigilances provides full or partial support for EU-QPPV activities, including:

  • global oversight of the European pharmacovigilance system
  • interface with European health authorities
  • 24/7 regulatory availability
  • validation and oversight of PV processes
  • review of product safety profiles
  • contribution to signal detection and evaluation
  • oversight of risk minimization activities
  • supervision of outsourced activities and business partners


Centralized and compliant governance designed to secure your pharmacovigilance activities across Europe.
Meet Specific French MAH Regulatory Requirements

In accordance with ANSM requirements, every French MAH must appoint a local Pharmacovigilance Responsible Person linked to the EU-QPPV function.

Atessia Vigilances performs French Local PV Responsible Person activities and supports MAHs with:

  • local oversight of pharmacovigilance activities
  • interactions with ANSM
  • monitoring of French regulatory obligations
  • inspection and audit management
  • coordination with global headquarters and international partners
  • oversight of local interfaces involving:
    • medical information
    • quality complaints
    • regulatory affairs


Strong expertise in French local requirements designed to ensure regulatory compliance and business continuity.
Build a Robust, Compliant, and Sustainable PV System

An efficient pharmacovigilance system relies on clear organization, controlled processes, and compliant documentation.

Our experts support:

  • creation or restructuring of PV systems
  • drafting and maintenance of local or global PSMFs
  • development of SOPs and quality documentation
  • definition of roles and responsibilities
  • optimization of safety data flows
  • compliance remediation of local and global activities


Systems designed to ensure traceability, operational efficiency, and regulatory compliance.
Prepare Effectively for EMA and ANSM Inspections

EU-QPPV and Local PV Responsible Person functions are key focus areas during pharmacovigilance inspections.

Atessia Vigilances supports organizations with:

  • preparation for EMA and ANSM inspections
  • mock inspections and interview simulations
  • internal and partner audits
  • gap assessments and CAPA plans
  • remediation of critical activities


A proactive approach designed to reduce regulatory risk and strengthen compliance levels.
Strengthen Regulatory Oversight Across Your Organization

We provide tailored training programs for teams involved in pharmacovigilance activities, including:

  • local and global PV teams
  • Responsible Pharmacists
  • regulatory affairs departments
  • medical information teams
  • quality and compliance functions


Our training programs cover:

  • GVP and regulatory requirements
  • French MAH obligations
  • Signal Management
  • inspection readiness
  • pharmacovigilance governance


Operational training programs designed to sustainably strengthen internal expertise and compliance.

Why Choose Atessia Vigilances?

Senior consultants experienced in MAH, affiliate, and global pharmacovigilance environments.

Compliance with ANSM, EMA, and Good Pharmacovigilance Practices expectations.

Processes and deliverables designed to withstand audits and regulatory inspections.

Full outsourcing, targeted support, or strategic consulting tailored to your operational needs.

Atessia Vigilances benefits from the historical expertise of AnticipSanté and the complementary expertise of the Atessia Group.

What You Gain by Working with Us

– Reduced regulatory risk
– Secured pharmacovigilance system oversight
– Control of local and European regulatory obligations
– Enhanced preparedness for inspections
– Strengthened safety governance

Looking for an EU-QPPV or a French Local Pharmacovigilance Responsible Person?

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the oversight and security of their pharmacovigilance activities across France and Europe.

Contact us