OFFICER – PHARMACOVIGILANCE

Roles and Responsibilities: Perform duplicate search in the global safety database and/or various logs/trackers using all possible/multiple criteria to identify the duplicate(s) of existing ICSR(s). Prioritize and process the cases retrieved/received from various sources like spontaneous, literature, regulatory, clinical studies/trials, BA/BE studies etc. Coding of events using the latest version of MedDRA and causality assessment of the reported events. Evaluation of the expectedness of the events by referring the latest PIs/SPCs/RSI/IBs. Writing the safety narrative. Perform follow-up with the reporter/author/concerned stake holder(s), as and when required. Coordinate with medical information contact center for collecting the follow-up information, as and when required. Quality review of the cases entered in the database for its quality and completeness. Submission of the eligible cases to regulatory agencies. Sharing of the eligible cases with concerned stake holder(s), as and when required. Attach/upload the acknowledgements of ICSRs in the global safety database. Resolve the queries related to the case processing activities. Update various logs/trackers related to case processing activities. Impart training on case processing activities to concerned stake holder(s), as and when required. Perform all other pharmacovigilance activities as assigned by HoD-GP