Drug Safety Associate I

BioClinica - Mysore, Karnataka - Essential Duties and Responsibilities: To author/draft aggregate reports like PBRER, PSUR, PADER, DSUR Hands on experience in authoring/drafting Risk management plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS) To perform quality review of aggregate reports, RMPs & REMS To draft/author safety assessment reports (SARs) To update RMP/REMS Hands on experience in handling regulatory queries with respect to aggregate reports, RMPs & REMS. Thorough knowledge on interpreting the various line listing documents Knows the metrics of pharmacovigilance with respect to aggregate report... - Permanent - Full-time

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