Pharmacovigilance Operations Lead
PuneFull-time6–11 yrsPosted open since jan 2026
Senior pharma role at Transperfect in Pune. Needs 6+ years.
About the role
Given the great interest in Pharmacovigilance Services at TransPerfect, the role will involve subject matter expertise in Literature Monitoring and further development of AI and automation solutions across wide ranging PV activities. Key responsibilities will involve bridging client relations, technology teams and streamlining project implementation through Subject Matter Expertise.
What you'll do
- Oversee daily surveillance and systematic triage of biomedical literature for safety signal detection
- Lead and refine global literature monitoring operations aligned with health authority expectations (FDA, EMA, MHRA, PMDA, etc.)
- Prepare for and participate in regulatory audits and inspections, implementing CAPAs and continuous improvement measures as required
- Establish, review, and update SOPs, workflows, to maintain regulatory compliance and inspection readiness
- Serve as internal Subject Matter Expert (SME), providing guidance on complex cases, compliance, and timely audit/inspection support
What you need
- Pharmacovigilance
- Documentation
- SOP writing
- RPA
- NLP
- Data privacy
Good to have
- CRO
- Six Sigma
- Lean