Job Title: Associate Director – Medical Review, Pharmacovigilance Operations
Company: GlaxoSmithKline (GSK)
Location: Bengaluru, India
Department: Medical & Clinical / Pharmacovigilance
Job ID: 432277
Employment Type: Full-Time
Experience Required: 9–12 years of experience in Medical Review within Pharmacovigilance, including Individual Case Safety Report (ICSR) assessment and safety evaluation activities.
About GSK
GlaxoSmithKline (GSK) is a global biopharmaceutical company committed to improving global health through innovative medicines and vaccines. The organization aims to positively impact the health of 2.5 billion people by the end of the decade through cutting-edge research, scientific excellence, and patient-focused innovation.
GSK integrates advanced technology, deep immunology expertise, and global scientific talent to accelerate the development of therapies in key therapeutic areas including oncology, respiratory diseases, immunology, infectious diseases, and HIV.
Role Overview
The Associate Director – Medical Review, PV Operations will provide strategic oversight of medical review activities conducted by the Global Service Provider (GSP). The role ensures that Individual Case Safety Report (ICSR) medical review activities meet GSK’s quality standards, regulatory expectations, and pharmacovigilance best practices.
This position collaborates closely with Safety Evaluation and Risk Management (SERM) teams, pharmacovigilance case processing teams, and global service partners to maintain high-quality safety data management while supporting continuous process improvements and regulatory compliance.
Key Responsibilities
Medical Review Oversight
Provide oversight of medical review activities performed by Global Service Provider (GSP) teams to ensure compliance with GSK standards and regulatory requirements.
Ensure that ICSR medical review deliverables meet defined quality benchmarks and internal safety standards.
Quality Assurance and Compliance
Perform quality checks of ICSR medical review activities to confirm that safety cases submitted to health authorities meet both regulatory and company expectations.
Evaluate listedness, expectedness, and causality assessments performed during medical review.
Operational Collaboration and Governance
Conduct regular meetings with GSP medical review leadership to evaluate case volumes, review quality metrics, and identify process improvement opportunities.
Act as a liaison between Safety Evaluation and Risk Management (SERM) teams, case processing units, and medical review teams.
Training and Capability Development
Develop and maintain structured training plans for GSP medical reviewers to ensure competency in medical review processes and regulatory guidelines.
Provide training and updates to SERM teams, pharmacovigilance case processing teams, and GSP staff on changes to medical review processes or safety regulations.
Continuous Process Improvement
Identify and implement process improvements in medical review workflows to enhance efficiency, quality, and regulatory compliance.
Promote standardization and optimization of pharmacovigilance medical review practices.
Performance Monitoring and Risk Escalation
Monitor and communicate key performance indicators (KPIs) related to medical review activities.
Escalate potential risks, compliance issues, or operational challenges to senior leadership when required.
Medical Support and Case Assessment
Provide expert medical support for complex or challenging safety cases.
Collaborate with case management and SERM teams to ensure accurate medical interpretation of safety data.
Compliance Investigations and CAPA Management
Participate in investigations related to compliance gaps or operational deviations.
Conduct gap analyses and support the development of corrective and preventive actions (CAPA).
Regulatory and Inspection Readiness
Ensure medical review processes remain compliant with global pharmacovigilance regulations.
Support audit and inspection readiness by presenting medical review strategies during internal audits and regulatory inspections.
Global Collaboration
Work within a global matrix environment involving pharmacovigilance teams, regulatory stakeholders, and service providers.
Collaborate with local operating companies (LOCs) when required to address country-specific regulatory requirements.
Educational Qualifications
Medical Degree (MBBS or equivalent) is mandatory.
Experience Requirements
Minimum 9–12 years of experience in pharmacovigilance medical review activities.
Extensive experience with Individual Case Safety Reports (ICSRs), including serious and non-serious case assessments.
Strong expertise in listedness, expectedness, and causality evaluation.
Practical experience with MedDRA coding conventions and pharmacovigilance databases.
Key Skills
Pharmacovigilance Expertise
Strong knowledge of global pharmacovigilance regulations and drug safety monitoring processes.
Safety Data Evaluation
Understanding of how ICSR medical review impacts signal detection, periodic safety reports, and regulatory safety communications.
Clinical Development Knowledge
Good understanding of clinical development processes and drug approval pathways across major regulatory markets.
Medical Judgment and Analytical Skills
Ability to make evidence-based medical decisions during safety case review.
Stakeholder Management
Proven ability to collaborate with cross-functional global teams and external service providers.
Leadership and Influence
Strong leadership skills with the ability to influence decision-making within a complex matrix organization.
Communication Skills
Excellent written and verbal communication skills in English with the ability to clearly present safety-related information.
Why Join GSK
GSK offers a dynamic environment where scientific expertise and innovation drive meaningful healthcare advancements. Employees have the opportunity to work on impactful global health initiatives while contributing to the development of safer medicines and vaccines.
The organization fosters a collaborative culture that encourages continuous learning, diversity, and professional growth while maintaining a strong commitment to patient safety and ethical research practices.
Equal Opportunity and Inclusion
GSK is committed to building an inclusive workplace and welcomes applications from diverse backgrounds. The company ensures equal employment opportunities and supports candidates who may require accommodations during the recruitment process.
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