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    Associate Director Regulatory Affairs - Oxford, Oxfordshire, United Kingdom - Jazz Pharmaceutical

    Jazz Pharmaceutical
    Jazz Pharmaceutical Oxford, Oxfordshire, United Kingdom

    1 month ago

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    Description
    If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (


    NASDAQ:

    We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.

    We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.

    We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.

    Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter.

    To lead Jazz's Pharmacovigilance QA (GvP) function to assure regulatory compliance and data integrity in all Jazz activities related to Pharmacovigilance.

    In collaboration with the Sr Dir, Clinical & PV QA, ensures the implementation of the Global Quality strategy, as relevant to pharmacovigilance (PV) QA.

    Supports implementation of Jazz's Quality Management System (QMS) as it applies to PV QA activities
    Verifies that data integrity principles are adhered to within Jazz's PV activities
    Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance Practice (GvP) and applicable Jazz SOPs
    Assesses and escalates to line management, the risk of any critical or major audit finding identified through audit activities

    Promotes GvP awareness amongst Jazz personnel and develops and maintains Jazz's GvP standards through the provision of training, review, advice and guidance services.

    to communicate this compliance posture to line management, including participation in the R&D-QMR.

    Manages and supports activities for Jazz related to GvP inspection readiness for inspections conducted by national and international regulatory authorities and other external bodies, such as marketing partners.

    In collaboration with the head of PV Compliance, leads projects to deliver improvements in productivity and efficiency in all areas relevant to pharmacovigilance, including leverage of Jazz Remix
    establishing personal networks and participating in professional societies.
    Works within the assigned budget for the Clinical & PV Quality group
    Leads or participates in other projects, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/Global Head of Quality
    Makes good decisions, based on a mixture of analysis, wisdom, experience, and judgement.

    Knowledgeable of FDA/EMA/MHRA and other relevant regulatory requirements applicable to PV; Bachelor's degree in life sciences or a related discipline.

    Post-graduate qualifications preferred (especially in Quality Management, PV, or related field).
    ~12+ years in pharmaceutical industry, including a minimum of 5 years in a leadership position within the bio/pharmaceutical industry.
    ~ Prior experience of working in bio/pharmaceutical R&D.
    ~ Extensive experience in GvP regulatory compliance requirements, with the ability to apply this knowledge to resolve day-to-day issues

    Jazz Pharmaceuticals is an Equal Opportunity Employer.
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