Job Summary

Contribute to medical safety activities within a global pharmaceutical setting 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 submissions.
Adhere strictly to established pharmacovigilance workflows and standard operating procedures to ensure timely case processing within agreed service levels and compliance with global health authority requirements.
Collaborate with cross functional pharmacovigilance and safety operations teams to clarify medical details resolve data discrepancies and support continuous improvement of safety review practices.
Maintain meticulous documentation of case handling decisions rationale and follow up

📌 TL-Medical Safety (Noida)
🏢 Cognizant
📍 Noida