- Provide medical and safety expertise for aggregate reports (DSURs, PBRERs, PSURs, etc ), including participation in kick-off meetings, review of key safety documents, and development of reporting strategies
- Conduct medical review, analysis, and interpretation of safety data, ensuring conclusions are clinically relevant, accurate, consistent, and compliant with regulatory requirements
- Collaborate closely with aggregate report authors and cross-functional stakeholders to address comments, refine assessments, and incorporate feedback from reviewers, QPPVs, and client safety physicians
- Support regulatory interactions by contributing to responses to health authority queries and reviewing safety documents to ensure compliance with global pharmacovigilance standards
- Manage and oversee the Medical Review team (Safety Physicians/Medical Reviewers) handling medical review of ICSRs and post-lock medical QC




- Own quality and turnaround metrics for medical review deliverables; drive root-cause analysis and CAPA for medical review defects
- Conduct resource planning, workload allocation, and capacity forecasting for the medical review team based on case volumes
- Provide clinical/medical guidance and calibration to Medical Reviewers on complex causality assessment, labeling, and listedness decisions
- Represent the medical review function in client governance calls; present quality trends and process improvements
- Conduct performance appraisals, mentoring, and career development for Medical Reviewers; ensure compliance with SOPs and regulatory timelines
- Support medical function for the assigned activities Must have Skill Set Medical & Pharmacovigilance ExpertiseRegulatory KnowledgeAggregate Reporting Medical Review
- Location: Pune,Bengaluru,Hyderabad,Mumbai

Contact Person Sangeetha Tamil

Email [email protected]

📌 Medical Reviewer - PV - Associate (Hyderabad)
🏢 Golden Opportunities
📍 Hyderabad