Jobs

    Director, Data Quality - Manchester, United Kingdom - Pharmiweb

    Pharmiweb
    Pharmiweb Manchester, United Kingdom

    3 days ago

    Default job background
    Description

    Provides direction and guidance to the PV Case Management function to ensure streamlined and efficient process, and fulfillment of support needed from other PV functions as well as other Regeneron functions.

    Maintains oversight of PV Case Management's deliverables, including but not limited to compliance and quality standards. Case Management vendors and study CROs to Regeneron management
    # Maintains oversight of PV Case Management's collaboration with other PV functions within and outside of PV to ensure provision of timely and high-quality PV data.
    # Maintains oversight of collaboration with License Partners on relevant PV deliverables to ensure compliance with Safety Data Exchange Agreements.
    # Exercises independent judgment in managing deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
    # Takes initiative in the ongoing process improvement for quality and compliance.
    # Authors new and updates to SOPs and Working Instructions, and conduct related training.
    # Leads continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all PV Case Processing deliverables, whether internal or external to the department.
    # Extensive experience with managing direct reports on complex projects.

    Equivalent experience (include # of years) in lieu of degree Associates Degree, Bachelors Degree, Masters Degree, Ph.
    Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required; We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

    Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

    We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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