Associate Medical Safety Director

Role & Responsibilities
• Lead end-to-end medical safety oversight for assigned products/studies, ensuring patient safety and regulatory compliance
• Provide medical review and clinical assessment of ICSRs, including serious/unexpected cases, special situations, and follow-up strategy
• Drive signal detection, signal evaluation, and risk–benefit assessment with clear medical justification and documentation
• Oversee authoring/review of aggregate safety deliverables (DSUR, PSUR/PBRER, RMP and related safety sections)
• Support safety governance activities, safety strategy, and client/stakeholder communications on safety topics
• Ensure adherence to global PV regulations and internal SOPs (including ICH, EMA, USFDA and local requirements)
• Guide quality, consistency, and timeliness of safety outputs; support audits/inspections and CAPA where required
• Mentor and provide scientific/medical guidance to safety scientists and case processing teams
• Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, Data Management, Biostats) to ensure data integrity and aligned safety decisions

Qualification
• MBBS/MD (preferred) or Pharmacy/Life Sciences (B.Pharm/M.Pharm/MSc) with strong pharmacovigilance expertise

Experience
• Significant experience in pharmacovigilance/drug safety with leadership responsibility (typically 8+ years overall, including medical review and aggregate reporting exposure)
• Demonstrated experience managing safety deliverables, safety strategy, and stakeholder/client interactions

Skills
• Medical review and clinical judgement for ICSR assessment
• Signal detection, risk management, and risk–benefit evaluation
• Aggregate report expertise (DSUR, PSUR/PBRER) and safety documentation (RMP)
• Strong knowledge of global PV regulations (ICH, EMA, USFDA) and inspection readiness
• Leadership, mentoring, and cross-functional communication
• High-quality scientific writing and decision documentation

About The Company
IQVIA India is part of IQVIA, a global leader in clinical research, advanced analytics, and technology solutions for the life sciences industry. The organization supports sponsors and partners across the drug development lifecycle with a strong focus on quality, compliance, and patient safety.