Pharmacovigilance- Quality Assurance- Assistant/Deputy Manager

4 weeks ago


Bangalore City, India Biocon Biologics Full time

We are looking for experienced candidate specifically from PV background and not from other functions/domains. A total experience of around 10 yrs with a mix of significant PV operations (6+ yrs) and minimal PV-QA (3+) experience is suitable.Roles and Responsibilities: PV-QAPrepare, review and control RQA-Clinical Quality SOPsReview and control Pharmacovigilance (PV) proceduresReview change controls, deviations, corrective and preventive actions (CAPAs), PQCs related to PVPerform and / or review vendor assessments related to PVPerform, report and close audits of PV systems, vendors, partnersReview PV documents and reports (e.G., aggregate reports such as DSUR, PSUR, PBRER, PADER), as per needImplement and / or maintain quality systems (GPvP)Undergo regular training related to GPvP; and train personnel on similar topicsMaintain documentation related to the aboveKnowledge of safety database (e.G., ArisG, Argus), and processing and review of safety cases and submission is preferred



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