Job Summary

Role involves managing end to end medical safety activities in a hybrid work model for global pharma research and development initiatives with focus on high quality safety data review and risk assessment while ensuring compliance with regulatory standards and supporting effective product benefit risk evaluation for improved patient outcomes and healthcare advancement

Responsibilities

Manage medical safety review activities for assigned products ensuring consistent evaluation of safety data and timely identification of potential risks to safeguard patient wellbeing and uphold regulatory expectations
Coordinate safety data collection and documentation for clinical and post marketing settings ensuring accurate entry of information and high quality narratives that support robust safety analyses
Conduct detailed medical safety assessments of individual case safety reports to confirm clinical relevance and clarity of reported events and to provide meaningful input into aggregate safety evaluations




Collaborate with cross functional pharma research and development teams to integrate safety insights into study design protocol amendments and development plans enhancing the scientific rigor and ethical standards of projects
Monitor emerging safety signals from internal databases and external sources and document medical rationale for signal validation escalation and follow up contributing to proactive risk management strategies
Prepare and review safety related documentation for regulatory submissions and internal governance meetings ensuring alignment with global safety regulations and company standards for medical accuracy
Support continuous improvement of safety review workflows by proposing enhancements to templates guidance documents and quality checklists that streamline case processing and improve consistency of medical assessments
Engage with pharmacovigilance case processing teams to clarify medical aspects of complex cases and to ensure that coding ser

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