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Associate Director, Medical Review, Pv Operations

Gsk Plc
GSK plc
9-12 years
Not Disclosed
Bengaluru, India
10 March 14, 2026
Job Description
Job Type: Full Time Education: MBBS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

GSK is hiring for the position of Associate Director – Medical Review, PV Operations in Bengaluru, India. The selected candidate will oversee medical review activities performed by global service providers and ensure alignment with GSK’s regulatory, quality, and pharmacovigilance standards.

The role involves working closely with Safety Evaluation and Risk Management (SERM) teams, ICSR medical reviewers, and case management teams to maintain high standards of safety review and regulatory compliance.

Key Responsibilities

  • Ensure that deliverables produced by ICSR medical reviewers meet GSK’s quality standards.

  • Perform quality checks on medical review activities and case assessments reported to regulatory authorities.

  • Collaborate with medical review leadership to evaluate case volumes, quality, and process improvements.

  • Develop and maintain training plans for medical reviewers to ensure competency and regulatory compliance.

  • Support training for SERM teams and case processing teams regarding updates to medical review processes.

  • Act as a liaison between safety teams, case processing teams, and medical review teams.

  • Promote continuous improvement initiatives in medical review processes.

  • Investigate non-compliance issues, perform gap analyses, and review operational metrics.

  • Communicate KPIs and escalate risks to senior pharmacovigilance leadership when necessary.

  • Provide medical support in complex case assessments and safety evaluations.

  • Ensure inspection readiness and adherence to global regulatory standards.

Required Experience

  • 9–12 years of experience in medical review and pharmacovigilance case assessment.

  • Expertise in listedness, expectedness, and causality assessment.

  • Strong understanding of MedDRA coding conventions.

  • Knowledge of global pharmacovigilance regulations and drug development processes.

  • Experience in quality management and KPI monitoring.

  • Strong leadership, communication, and stakeholder management skills.


Apply Details

Interested candidates can apply through the official careers page of GSK.