Pharmacovigilance Services Specialist (Medical Review)
Role Level: Team Lead / Consultant
Location: Chennai, India
Job Type: Full-Time
Experience Required: 7–11 Years
Job ID: AIOC-S01621378
Job Overview
We are seeking an experienced Pharmacovigilance Services Specialist (Medical Review) to lead medical assessment activities across global drug safety programs. This role is designed for senior medical professionals with deep expertise in ICSR medical review, causality assessment, labeling, and regulatory compliance.
The position plays a critical role in ensuring accurate, timely, and compliant safety evaluations in line with client SOPs and global regulatory requirements, while also supporting team leadership, training, and process optimization initiatives.
Key Responsibilities
Medical Review & Safety Assessment
Perform medical review of Individual Case Safety Reports (ICSRs) within defined SLAs and regulatory timelines
Assess and confirm seriousness, expectedness, labeling, and causality of adverse events in compliance with client SOPs
Review source documents and case narratives to ensure medical accuracy and regulatory completeness
Draft and approve company causality comments and route cases to appropriate workflows
Quality, Compliance & Regulatory Readiness
Ensure all safety cases meet global regulatory standards and client quality metrics
Conduct self-reviews and E2B validation checks prior to case progression
Validate data consistency and update safety databases as required
Respond to medical and regulatory queries from internal teams, clients, license partners, and health authorities
Leadership, Training & Stakeholder Engagement
Lead training initiatives for case processors, quality reviewers, literature reviewers, and cross-functional teams
Provide medical guidance and resolution for safety-related queries across the case lifecycle
Participate in case discussions with clients and provide expert medical insights
Support process transitions, knowledge transfer, and continuous improvement initiatives
Process Oversight & Documentation
Contribute to pharmacovigilance governance, SOP compliance, and audit readiness
Support preparation of pharmacovigilance agendas, meeting minutes, and documentation
Assist in transition activities and provide approvals in line with SOPs and SWIs
Stay current with evolving pharmacovigilance regulations, client requirements, and operational changes
Required Qualifications
MBBS or MD (mandatory)
7–11 years of experience in pharmacovigilance, drug safety, or medical review roles
Strong expertise in ICSR medical assessment, causality evaluation, and labeling review
Hands-on experience with global safety databases
Working knowledge of MedDRA and WHO-Drug (WHODD) dictionaries
Proficiency in MS Word, Excel, and documentation tools
Excellent medical writing, analytical, and communication skills
Strong command of English (written and verbal)
Core Competencies
Advanced clinical judgment and risk-benefit assessment
Strong regulatory compliance and quality mindset
Ability to lead teams and mentor junior safety professionals
Effective stakeholder and client communication
Adaptability to evolving regulatory and operational environments
Why Join This Role?
Leadership opportunity within global pharmacovigilance programs
High-impact medical review role supporting patient safety worldwide
Exposure to international clients, regulatory authorities, and complex safety cases
Platform to drive process excellence, team capability building, and compliance oversight
SEO & GEO Keywords
Pharmacovigilance Medical Review Jobs India, PV Specialist MBBS Chennai, Drug Safety Physician Jobs, ICSR Medical Reviewer India, Senior Pharmacovigilance Consultant, MedDRA WHO Drug Coding Medical Review Roles.
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