Pharmacovigilance Associate

Key ResponsibilitiesReceive, record, and process Individual Case Safety Reports (ICSRs) from clinical trials, healthcare professionals, patients, and literature sources.Ensure timely entry of adverse event data into the safety database in compliance with regulatory timelines.Assist in coding adverse events using MedDRA terminology and verifying case accuracy.Support preparation of expedited safety reports and aggregate reports (e.g., DSURs, PSURs).Help maintain safety files and documentation in accordance with internal SOPs and regulatory requirements.Monitor literature sources for potential adverse event reporting.Provide administrative and operational support to the PV team, including safety data reconciliation with partners and CROs.Assist during audits, inspections, and regulatory queries by preparing necessary safety documentation.Participate in PV-related training and continuous improvement activities.