Associate Director – Medical Review, PV Operations
Location: Bengaluru, Karnataka, India
Employment Type: Full Time
Function: Medical & Clinical | Pharmacovigilance Operations
Industry: Biopharmaceuticals
Job ID: 432277
Posted Date: January 22, 2026
Work Site: Bengaluru – Luxor North Tower
About GSK
GSK is a global biopharmaceutical company focused on uniting science, technology, and talent to get ahead of disease together. With an ambition to positively impact the health of 2.5 billion people by the end of the decade, GSK develops and delivers innovative vaccines and medicines across core therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases.
Role Overview
The Associate Director – Medical Review, PV Operations is a senior leadership role responsible for providing strategic and operational oversight of Individual Case Safety Report (ICSR) medical review activities conducted by Global Service Providers (GSPs). This position ensures alignment with GSK standards, global regulatory requirements, and best-in-class pharmacovigilance practices.
The role works closely with Safety Evaluation and Risk Management (SERM) teams, ICSR case management teams, and external safety partners to drive quality, consistency, inspection readiness, and continuous improvement across medical review operations.
Key Responsibilities
Medical Review Oversight & Quality Management
Ensure medical review deliverables produced by GSP medical reviewers meet GSK quality, scientific, and regulatory standards.
Perform quality checks on ICSR medical reviews, including listedness/expectedness and causality assessments, to ensure regulatory compliance.
Monitor and evaluate quality metrics, KPIs, and trends related to medical review performance.
Vendor & Stakeholder Management
Partner with GSP medical review leadership to review workload, quality outcomes, complex cases, and learning opportunities.
Serve as the primary liaison between SERM teams, ICSR case processing teams, and GSP medical reviewers to ensure alignment and effective communication.
Support onboarding, training, and ongoing competency development for GSP medical reviewers.
Process Improvement & Compliance
Lead and implement continuous improvement initiatives across medical review processes and content.
Contribute to investigations of non-compliance, gap analyses, root cause analyses, and CAPA development.
Ensure inspection readiness and support internal and external audits and regulatory inspections.
Escalate risks, issues, and adverse trends to senior leadership, global process owners, and quality governance forums.
Medical & Scientific Leadership
Provide expert medical guidance on complex or high-risk safety cases.
Support signal detection, periodic safety reports, regulatory responses, and downstream safety surveillance activities.
Collaborate with Local Operating Companies (LOCs) to support country-specific medical review and regulatory requirements.
Present medical review strategies and outcomes at internal governance forums as required.
Education & Experience Requirements
Educational Qualifications
Degree in Medicine, Pharmacy, Life Sciences, or a related scientific discipline (mandatory).
Advanced clinical degree (MD, PharmD) or relevant postgraduate qualification is preferred.
Experience Required
Minimum 9–12 years of experience in pharmacovigilance medical review, covering all ICSR case types.
Demonstrated expertise in causality assessment, listedness/expectedness evaluation, and MedDRA coding conventions.
Strong experience in quality management, KPI oversight, and vendor governance within PV Operations.
Proven understanding of the impact of medical review on signal detection, aggregate reporting, and regulatory submissions.
Technical & Leadership Skills
In-depth knowledge of global pharmacovigilance regulations and drug approval processes in major markets.
Strong medical judgment with the ability to make sound, evidence-based decisions.
Experience working in complex, global matrix environments.
Excellent written and verbal English communication skills.
Demonstrated leadership, stakeholder engagement, and influencing capabilities.
Preferred Experience
Experience in signal detection, aggregate safety reporting, and Risk Management Plans.
Prior people management or team leadership experience within PV Operations.
Familiarity with regulatory inspection expectations and audit response management.
Experience working with CROs, safety vendors, or external service providers.
Why Join GSK
Competitive base salary with annual performance-based bonus
Flexible working options for eligible roles
Comprehensive healthcare and wellbeing programs
Strong learning, leadership development, and career progression opportunities
Inclusive, ethical, and patient-focused organizational culture
Inclusion & Equal Opportunity
GSK is committed to fostering an inclusive workplace and encourages applicants to request adjustments during the recruitment process if needed.
Important Notice
GSK does not charge any fees during the recruitment process and does not accept unsolicited agency referrals without prior authorization. Candidates are advised to remain alert to fraudulent job postings.
Apply via thepharmadaily.com to explore senior leadership opportunities in Pharmacovigilance and Medical Safety with GSK.
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