Job Title: Medical Reviewer
Location: Mumbai, India (Other locations: Pune, Bangalore, Hyderabad)
Experience: 3–20 years
Job Type: Full-Time
Category: Pharmacovigilance / Clinical Safety / Medical Review
TCS is seeking an experienced Medical Reviewer to join our pharmacovigilance and clinical safety team. The role is ideal for medical professionals with a strong background in clinical assessment and regulatory compliance. The Medical Reviewer will ensure the accuracy, completeness, and regulatory alignment of medical reviews across clinical, solicited, and spontaneous cases, contributing directly to patient safety and drug safety monitoring.
Conduct comprehensive medical reviews of adverse events (AEs), serious adverse events (SAEs), literature cases, and other solicited/spontaneous reports.
Perform medical assessment, including labeling and causality evaluation, and prepare company causality statements.
Review the clinical relevance and accuracy of narratives, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and patient medical history.
Ensure global consistency in coding, seriousness assessment, and regulatory compliance for all cases.
Maintain up-to-date knowledge of disease biology, pharmacology, safety concerns, and clinical implications for marketed drugs and investigational products.
Collaborate with cross-functional teams to ensure high-quality safety data reporting and regulatory submissions.
Educational Qualification: MBBS, MD.
Experience: 3–20 years in medical review, pharmacovigilance, or clinical safety roles.
Strong knowledge of drug safety regulations, ICH-GCP guidelines, and global pharmacovigilance standards.
Excellent analytical and decision-making skills for accurate case assessment and reporting.
Ability to interpret complex clinical data and maintain high-quality documentation.
Strong communication and teamwork skills, with attention to detail and regulatory compliance.
Work with a leading global organization with a strong focus on patient safety and pharmacovigilance.
Gain exposure to global drug safety standards, clinical review processes, and regulatory submissions.
Collaborate with experienced medical and clinical professionals across multiple therapeutic areas.
Competitive compensation and career development opportunities within the clinical safety domain.
Apply Now: Submit your CV/resume via the TCS careers portal or through our online application process.
TCS is an Equal Opportunity Employer and values diversity, equity, and inclusion in all aspects of employment.
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