Medical Reviewer - PV - Associate
Location: Pune, Bengaluru, Hyderabad, Mumbai
• Experience: Senior Level
• Openings: 3
Job description
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 Expertise
Regulatory
Knowledge
Aggregate
Reporting
Medical
Review