About the Role
About the Role
The PV / Safety Auditor – Mid Level will conduct pharmacovigilance and drug safety audits, ensuring compliance with global PV regulations and supporting quality improvement initiatives across PV programs.
Key Responsibilities
• Conduct PV and Drug Safety audits (system, process, and compliance)
• Review PV SOPs, safety processes, and documentation for regulatory compliance
• Identify audit findings, risks, and gaps; prepare clear audit reports
• Support CAPA development, implementation, and follow-up
• Contribute to inspection readiness and audit preparedness activities
• Collaborate with internal teams and external stakeholders during audits
Requirements
• 5–10 years of experience in Pharmacovigilance / Drug Safety audits
• Strong knowledge of ICH E2 guidelines, GVP Modules, and GxP standards
• Hands-on experience with PV Quality Management Systems (QMS)
• Good documentation, analytical, and communication skills