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    Pharmacovigilance- Quality Assurance- Assistant/Deputy Manager - Delhi, India - Biocon Biologics

    Biocon Biologics
    Biocon Biologics Delhi, India

    3 weeks ago

    Default job background
    Description

    We are in search of a skilled candidate with a specific background in PV, not from other areas. A total of approximately 10 years of experience is required, with a focus on significant PV operations (6+ years) and some PV-QA experience (3+ years).


    Roles and Responsibilities:
    - Prepare, 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 PV
    - Perform and/or review vendor assessments related to PV
    - Conduct, 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 needed
    - Implement and/or maintain quality systems (GPvP)
    - Participate in regular training on GPvP; and provide training to staff on similar subjects
    - Maintain relevant documentation
    - Familiarity with safety databases (e.g., ArisG, Argus), and processing/review of safety cases and submissions is advantageous

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