GVP Auditor

Location:

Europe (Remote) Travel:

Occasional client site visits (rare) Contract:

Consulting Language :

French speaking

About the Role We are looking for an experienced

GVP Auditor

to join our growing consultancy team. You will provide

independent, risk-based assurance

that our clients’ pharmacovigilance (PV) systems meet regulatory requirements and protect patient safety. You’ll work across a wide range of organisations—from start-up biotechs to global pharmaceutical companies—supporting compliance with

EU Good Pharmacovigilance Practice (GVP)

and expectations from regulators such as the

European Medicines Agency .

What You’ll Do Plan and deliver

risk-based PV audits

(system, process, vendor, and affiliate) Assess key PV activities, including: ICSR processing Signal detection and management Literature monitoring Aggregate reporting (PSURs / PBRERs) Risk Management Plans Quality Management Systems Oversight of outsourced providers Review documentation, sample safety cases, and interview PV staff and QPPVs Identify and classify findings (Critical, Major, Minor) and write clear audit reports Review CAPAs, root cause analyses, and verify effectiveness Support inspection readiness (mock inspections, PSMF review, gap assessments) Provide advisory support (SOP review, training, QMS improvements) while maintaining audit independence

What We’re Looking For Strong knowledge of

EU PV legislation and GVP modules Experience auditing or working within pharmacovigilance systems Excellent risk assessment, analytical, and report-writing skills Confidence working with senior stakeholders and regulators Ability to manage multiple clients and deadlines Willingness to travel when required