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Quality and Training Specialist-Pharmacovigilance (PV)
Remote · India
Job Summary
Quality and Training Specialist-Pharmacovigilance (PV) responsible for designing and delivering PV training programs, conducting real-time quality analysis of PV deliverables, maintaining SOPs and project guidelines, supporting PV audits/inspections, and driving GPV process improvements. Leads training initiatives, ensures readiness for PV audits, develops quality metrics, and collaborates with cross-functional teams, CROs, and vendors to ensure compliance with GPV regulations and quality governance. Requires 7+ years PV experience, 5+ years in PV quality roles, and Bachelor’s or Master’s in Pharmacy or Life Sciences; advanced knowledge of global GPV regulations and QA excellence in regulated environments. Thermo Fisher Scientific is an equal opportunity employer. Please contact for accommodations.
Required Qualifications
- Bachelor’s or Master’s degree in Pharmacy or Life Sciences
- 7+ years of PV experience
- 5+ years in PV quality roles
- experience developing quality systems
- managing risk-based PV audit programs
- implementing process improvements
- strong knowledge of global GPV regulations
- expertise in audits/inspections
- communication and stakeholder management skills
- experience with electronic systems in regulated environments (drug safety, LMS, documentation management)
Additional Requirements
- None specified
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