Job Summary

This hybrid role is for a specialist skilled in pharmacovigilance with experience in pharma research and development focused on ensuring high quality safety data and regulatory compliance for global markets. The role involves daily case review safety data analysis and collaboration with cross functional teams to support safer therapies for patients worldwide.

Responsibilities

Perform pharmacovigilance case intake activities by reviewing source documents verifying completeness of safety information and ensuring accurate capture of relevant medical data to maintain high quality case processing standards.
Execute detailed case assessment activities by evaluating seriousness causality and expectedness based on clinical and scientific judgment to support consistent safety signal interpretation.
Document adverse events and product complaints in safety databases by entering structured and narrative information with strong attention to accuracy and consistency to comply with internal and regulatory requirements.




Collaborate with cross functional colleagues in clinical development medical affairs and regulatory functions by sharing safety insights to support informed benefit risk evaluations for investigational and marketed products.
Apply pharma research and development knowledge by interpreting clinical protocols investigator brochures and development safety update reports to ensure case evaluation aligns with project objectives.
Conduct ongoing case follow up by tracking pending information coordinating with partners and updating records to maintain complete and reliable pharmacovigilance data sets.
Review safety data outputs such as line listings and summary tables by identifying inconsistencies and trends to support aggregate safety reporting and risk management activities.
Support process improvement initiatives by identifying recurring issues in data entry documentation and case routing to enhance overall efficiency and quality of pharmacovigilance

📌 SPE-Pharmacovigilance (Pune)
🏢 Cognizant
📍 Pune