TL-Medical Safety

Cognizant · Noida, Uttar Pradesh · Posted 3 days ago

About this role

Job Summary Contribute to medical safety activities within a global pharmaceutical environment by supporting end to end safety case review and documentation for clinical and post marketing products. Apply knowledge of pharma research and development and pharmacovigilance operations to ensure robust assessment of individual case safety reports while collaborating in a hybrid work model to uphold patient safety and regulatory compliance across diverse therapeutic areas. Responsibilities • Perform systematic medical safety review of individual case safety reports to ensure accurate assessment of seriousness causality and clinical relevance in alignment with internal standards and global regulatory expectations. • Apply foundational knowledge of pharma research and development to interpret clinical trial data product labels and risk benefit profiles when evaluating reported adverse events and safety signals. • Execute end to end case processing activities including medical evaluation narrative refinement coding verification and consistency checks to maintain high quality safety data within applicable systems. • Conduct thorough verification of source documents and supporting clinical information to confirm case validity completeness and coherence while escalating unclear or conflicting data for clarification. • Participate in routine safety review meetings by providing concise case level insights that support aggregate safety assessments risk mitigation strategies and regulatory