About the Role
About the Role
The PV / Safety Auditor – Senior Level will lead and manage complex pharmacovigilance audits, ensure inspection readiness, and provide strategic oversight for global PV compliance programs.
Key Responsibilities
• Lead end-to-end PV and Safety audits, including internal, external, and vendor audits
• Act as Lead Auditor for PV systems, processes, and compliance frameworks
• Review and approve audit strategies, risk assessments, and reports
• Support regulatory inspections, mock audits, and inspection readiness activities
• Oversee CAPA strategy, implementation, and effectiveness checks
• Mentor and guide junior auditors and PV quality teams
• Act as subject matter expert for PV compliance and governance discussions
Requirements
• 10+ years of experience in Pharmacovigilance / Drug Safety auditing
• Expert knowledge of global PV regulations, GVP, ICH E2, and inspection expectations
• Proven experience managing regulatory inspections and audits
• Strong leadership, stakeholder management, and client-facing skills