Ensure PV project teams are fully equipped with skills and quality oversight
Design and deliver training programs for PV project teams
Conduct real-time quality analysis of project deliverables
Maintain and update SOPs, work instructions, and client procedural documents
Support development and reporting of PV compliance metrics
Lead escalation and cross-functional process improvement activities related to GPV quality issues
Ensure readiness for PV audits and inspections
Serve as the primary contact for PV-related quality assurance matters
Present quality trends and recommendations to stakeholders
Mentor and train colleagues, collaborating with cross-functional teams, CROs, and vendors

Bachelor’s or Master’s degree in Pharmacy or Life Sciences
7+ years of relevant Pharmacovigilance (PV) experience
5+ years in PV quality roles supporting audits, inspections, and GPV compliance activities
Strong knowledge of global GPV regulations (FDA, ICH, CDSCO-PvPI, EU GVP; PMDA preferred)
Expertise in audits/inspections and development of responses
Advanced understanding of QMS, process improvement, and quality governance
Ability to manage complex projects and lead training initiatives
Experience with electronic systems used in regulated environments (drug safety, LMS, documentation management)

Quality and Training Specialist – Pharmacovigilance

About this role