15 June, 2022
Role: Aggregate reporting, pharmacovigilance
Experience: 2-3yrs in aggregate reporting
Prepare periodic safety reports on products that are in development (DSUR, IND Annual Report) or that have been granted regulatory approval (PADERs, PSURs and PBRERs, Signals etc.).
To generate ICSRs and Product complaints line listings as per the project requirement.
Analyse and present the clinical and safety data on benefit- risk assessment in documents.
Safety data collection and consolidation for report preparation.
Narrative writing and review.
Perform quality control activities to ensure complete and accurate information has been documented.
Support in preparation of submission readiness of aggregate reports.
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