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Weybridge

    Senior Manager for Quality Management - Weybridge, Surrey, United Kingdom - Hobson Prior International Ltd

    Hobson Prior International Ltd
    Hobson Prior International Ltd Weybridge, Surrey, United Kingdom

    4 days ago

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    Description
    Hobson Prior is seeking a Senior Pharmacovigilance Manager. The successful candidate will maintain the overall safety profiles and any emerging safety concerns concerning the pharmaceutical products. This role is crucial in managing all pharmacovigilance risk management issues and acting as the UK National Contact Person.
    For this role, you will manage day-to-day operations of the Pharmacovigilance Team.
    Continuously monitoring the safety profiles of medicinal products and conducting ongoing safety evaluations throughout the post-authorization period.

    Supervising Individual Case Safety Reports (ICSRs), Standard Operating Procedures (SOPs), aggregate reports (Periodic Safety Update Reports - PSURs and Periodic Adverse Drug Experience Reports - PADERs), and Safety Data Exchange Agreements (SDEAs).

    Serving as a Pharmacovigilance Subject Matter Expert (SME) for Risk Management Plans (RMPs), Post-Authorization Safety Study (PASS) protocols, Risk Minimization Strategies, effectiveness assessments of follow-up measures, post-marketing commitments, and electronic transmissions to competent authorities.

    Ensuring readiness for Pharmacovigilance audits and inspections, facilitating successful outcomes, and promptly addressing and closing any findings.

    Implementing and maintaining the 5-year audit plan for Pharmacovigilance, ensuring consistent execution and periodic review to ensure full auditing coverage on a rolling 5-year basis.

    Reviewing and approving aggregate reports (PADERs and PSURs), Risk Management Plans, particularly those pertaining to drug safety, to uphold quality standards and ensure accuracy and transparency of benefit/risk information.

    Hold a Medical or Life Science Degree
    Substantial experience in the pharmaceutical industry, particularly in pharmacovigilance.
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