TCS is seeking a Medical Reviewer to support the medical review and assessment of adverse event reports, ensuring the accuracy, quality, and regulatory compliance of pharmacovigilance and drug safety activities.
The Medical Reviewer will collaborate with Drug Safety teams, pharmacovigilance professionals, and cross-functional stakeholders to review individual case safety reports, provide medical expertise, support regulatory compliance, and ensure the effective evaluation of safety information throughout the product lifecycle.
Key Responsibilities Perform medical review and assessment of adverse event and drug safety cases.
Evaluate case narratives, laboratory data, medical history, concomitant medications, and suspect products.
Assess medical causality, seriousness, and labeling relevance of safety cases.
Review and respond to queries related to individual case safety reports.
Generate and track medically relevant follow-up requests for additional safety information.
Support Drug Safety teams with medical expertise and product-related knowledge.
Ensure compliance with regulatory requirements, SOPs, and pharmacovigilance processes.
Participate in audits, safety reviews, and stakeholder discussions.
Skills

📌 Medical Reviewer (Xico)
🏢 Tata Consultancy Services
📍 Xico