Associate Director, Medical review, PV Operations

Role & Responsibilities
• Oversee ICSR medical review activities performed by Global Service Providers (GSP)
• Perform quality checks on medical review deliverables for regulatory and company compliance
• Review listedness/expectedness and causality assessments
• Lead training and competency development for medical reviewers
• Act as liaison between SERM, ICSR processing teams and medical review vendors
• Monitor KPIs, identify gaps, drive CAPA and continuous improvement initiatives
• Support audit readiness, inspections, and regulatory compliance activities
• Provide medical guidance on complex and high-risk safety cases
• Support local operating companies on medical review processes when required

Qualification
• Advanced clinical degree preferred (MD / PharmD / Postgraduate Medical Qualification)

Experience
• 9–12 years of pharmacovigilance medical review experience

Skills
• Strong expertise in ICSR medical review, causality & listedness assessment
• In-depth knowledge of MedDRA coding conventions
• Expertise in quality management, KPI monitoring, and CAPA management
• Strong understanding of global PV regulations and drug approval processes
• Excellent medical judgment, analytical thinking, and communication skills
• Leadership ability and stakeholder management in matrix environments
• Experience with audits, inspections, CRO/vendor oversight

About the Company
GSK is a leading global biopharmaceutical company focused on vaccines and specialty medicines across respiratory, immunology, oncology, HIV and infectious diseases. With a mission to positively impact 2.5+ billion people by 2030, GSK unites science, technology and talent to deliver innovative, high-quality, patient-focused healthcare solutions worldwide.