Tata Consultancy Services (TCS) is a global leader in IT services, consulting, and business solutions. With a strong presence in healthcare and life sciences, TCS provides innovative solutions to pharmaceutical and biotech companies. TCS is known for its robust pharmacovigilance services, ensuring drug safety and regulatory compliance worldwide.
Job Description: Medical Reviewer
As a Medical Reviewer at TCS, you will be responsible for ensuring accurate medical evaluation and reporting of adverse events (AEs) and special safety cases. Your role will involve:
Key Responsibilities:
✔ Medical Review: Assess non-serious & serious cases, special situations (without AEs), and non-valid cases per SOPs.
✔ Medical Evaluation: Perform event assessment, seriousness determination, labeling, and causality assessment.
✔ Case Accuracy Check: Verify medical coding (MedDRA & WHO-DD), narrative completeness, and company causality comments (CCC).
✔ Follow-up Actions: Generate queries for reporters, request additional PV information, and ensure timely feedback.
✔ Literature Screening: Identify potential safety signals and create ICSRs (Individual Case Safety Reports).
✔ Compliance: Adhere to pharmacovigilance regulations, user manuals, and working instructions.
Required Skills & Qualifications:
- MBBS/MDÂ degree mandatory.
- 2-3 years of experience in pharmacovigilance, drug safety, or clinical research.
- Strong knowledge of MedDRA, WHO-DD, and case processing guidelines.
- Ability to analyze medical data and ensure regulatory compliance.
