Audits & Training

Pharmacovigilance Audits & Training

Pharmacovigilance Audits & Training

Sustainably Strengthen Compliance and Oversight of Your Pharmacovigilance Activities

Within a regulatory environment governed by Good Pharmacovigilance Practices (GVP), pharmaceutical companies, Marketing Authorization Holders (MAHs), and Life Sciences organizations must ensure the robustness of their quality systems while maintaining a high level of operational oversight.

Quality audits and training programs are essential levers to:

– identify compliance risks

– improve pharmacovigilance processes

– secure outsourced activities

– strengthen quality governance

– develop operational and regulatory team competencies

Atessia Vigilances supports pharmaceutical companies, biotech firms, and MAHs in the assessment, optimization, and continuous improvement of their pharmacovigilance systems through a pragmatic, operational, and compliance-driven approach aligned with EMA and ANSM expectations.

Our objective: to sustainably strengthen your regulatory compliance and the oversight of your vigilance activities.

Assess the Robustness of Your PV Systems and Processes


Pharmacovigilance systems must ensure regulatory compliance, safety data quality, and control over critical processes.


Atessia Vigilances performs audits tailored to your organization and regulatory challenges, including:


  • internal pharmacovigilance audits
  • PV Quality System audits
  • France and Europe regulatory compliance audits
  • distributor and partner audits
  • vendor and outsourced activity audits



Our assessments notably cover:


  • PV system organization
  • case management and regulatory timelines
  • EudraVigilance activities
  • quality and documentation processes
  • EU-QPPV and Local Pharmacovigilance Responsible Person (LPPV/RPV) responsibilities
  • traceability of safety activities



Comprehensive assessments designed to strengthen the reliability, compliance, and oversight of your pharmacovigilance system.

Secure the Compliance of Your Vendors and Distributors


Outsourced pharmacovigilance activities require rigorous oversight to ensure operational compliance and proper management of regulatory responsibilities.


Our teams support you with:


  • vendor and subcontractor assessments
  • local distributor audits
  • review of PV contractual obligations
  • assessment of Pharmacovigilance Agreements (PVAs)
  • verification of safety data exchange flows and responsibilities
  • quality oversight of outsourced activities



Strengthened governance designed to mitigate risks associated with outsourced pharmacovigilance activities.

Strengthen the Expertise of Your Teams


Strong knowledge of regulatory requirements and pharmacovigilance best practices is essential to ensure the quality of safety activities and reduce compliance risks.


Atessia Vigilances designs and delivers customized training programs tailored to your operational needs and business activities, including:


  • operational pharmacovigilance
  • medical information
  • case management and regulatory reporting
  • French MAH obligations
  • GVP and EMA / ANSM requirements
  • clinical trial safety and pharmacovigilance
  • Signal Management
  • Pharmacovigilance Quality Management Systems (PV QMS)



Practical, operational, and directly applicable training programs designed for day-to-day vigilance activities.

A Flexible and Operationally Focused Approach


Our training programs are developed according to:


  • your regulatory maturity level
  • your products and activities
  • your operational challenges
  • participant profiles and responsibilities



Available formats include:


  • on-site training sessions
  • remote sessions and virtual classrooms
  • operational workshops
  • case studies and practical exercises
  • dedicated programs for Responsible Pharmacists, EU-QPPVs, and PV teams



A pragmatic learning approach designed to sustainably strengthen team competencies and regulatory compliance.

Systems Designed to Be Robust, Compliant, and Auditable


Our activities are based on:


  • Good Pharmacovigilance Practices (GVP)
  • EMA and ANSM requirements
  • quality standards applicable to PV systems
  • risk-based methodologies



We ensure:


  • robust methodologies
  • pragmatic assessments
  • operational recommendations
  • improvement plans tailored to your constraints
  • continuous improvement of your quality systems



A quality-driven approach designed to sustainably secure your pharmacovigilance system.

Why Choose Atessia Vigilances?

Experienced consultants specialized in PV audits, quality systems, and regulatory compliance.

Compliance with EMA, ANSM, and GVP expectations.

Recommendations tailored to your operational realities and organizational environment.

Audits and training programs designed to sustainably strengthen your compliance level.

Targeted support or long-term structured programs adapted to your needs.

What You Gain by Working with Us

– Strengthened regulatory compliance
– Reduced risk of non-compliance
– Continuous improvement of PV processes
– Enhanced team competencies
– Sustainable security of your pharmacovigilance activities

Looking for a Partner in PV Audits & Training?

Atessia Vigilances supports pharmaceutical companies, biotech firms, and Life Sciences organizations in the assessment, optimization, and security of their pharmacovigilance and regulatory vigilance systems.

Contact us