Major purpose of the Job: • To be responsible for day-to-day medical reviewing of Individual Case Safety Report (ICSRs) in safety database, with the objective of achieving a high level of regulatory compliance. • Medical Review of ICSR, Periodic Safety Update Report (PSUR), Periodic Adverse Drug Experience Report (PADER), Risk Management Plan (RMPs), Addendum to Clinical Overview (ACO), Risk Evaluation and Mitigation Strategy (REMS) and Signal reports. • To Review Summary of Product Characteristic (SmPC), Package Insert (PI) and Patient Information Leaflet (PIL). • To perform causality and provide medical judgement. Responsibilities: 1. Perform medical review of ICSRs from clinical trials, post-marketing, literature, and other sources. 2. Medical Review of aggregate reports (PSUR, PADER, RMP, REMS) and Signal reports. 3. Responsible for maintaining signal detection tracker. 4. Management of other work/responsibilities as allocated by Head of Pharmacovigilance or designee. 5. Training of new joinee on medical review role. 6. Responsible for providing medical judgment for safety variation activity. 7. To assist pharmacovigilance department for handling regulatory queries and Request for Information (RFI). 8. To assist the Medical Head in preparation for any internal audits or external inspections on Cadila Pharmaceuticals Limited, Pharmacovigilance function. 9. Development of training modules and organizing training for staff of PV department as PVOIC. 10. Identification of PV activities and framing of SOPs, revision of SOPs as PVOIC. 11. Act as a single contact point for the competent authority on a 24-hour basis as PVOIC.
