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Pharmacovigilance- Quality Assurance- Assistant/deputy Manager
2 weeks ago
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 SOPs Review and control Pharmacovigilance (PV) procedures Review 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, partners Review PV documents and reports (e.g., aggregate reports such as DSUR, PSUR, PBRER, PADER), as per need Implement and / or maintain quality systems (GPv P)Undergo regular training related to GPv P; and train personnel on similar topics Maintain documentation related to the above Knowledge of safety database (e.g.
, Aris G, Argus), and processing and review of safety cases and submission is preferred-
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