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  • Manager, Global Safety Compliance - North Chicago - AbbVie

    AbbVie
    AbbVie North Chicago

    2 weeks ago

    Default job background
    Full time
    Description

    Job Description

    A global leader in biopharmaceuticals, AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

    Purpose:

    The purpose of this role is to support Safety Compliance leadership to develop, implement, maintain and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization. This system must at a minimum meet global regulatory legal requirements and standards, and promote best practice and excellence.

    The role primarily supports all tasks associated with the implementation of the Pharmacovigilance (PV) Investigation / CAPA and Planned Deviation process within the Pharmacovigilance and Patient Safety (PPS) organization. Additionally, supporting audits/inspections impacting the PV system.

    The scope extends to Pharmacovigilance (PV) activities worldwide and spans the life cycle of all products.

    Responsibilities:

    • Independently resolves routine issues. Handles complex problems by proposing potential solutions to management. Contributes to departmental policy.
    • Review, develops, and monitors global pharmacovigilance compliance metrics.
    • Leads the preparation and conduct of PV relevant, internal, and external global audit and inspection process, responses and develops associated improvement plans.
    • Review and triage of reports of non-conformances and potential non-conformances using professional judgement and expertise.
    • Review and approve exception reports, planned deviations and CAPA tasks in line with internal and regulatory requirements.
    • Review, evaluates and proposes necessary changes to regulatory guidance.
    • Evaluates and develops appropriate work tools and methodologies to enable staff to continually improve performance and productivity.
    • Actively identify, propose, and implement improvements while fully engaging in new initiatives to continually support the advancement of the Audit/Inspection process, PV investigation/CAPA process and Planned Deviation process.

    This role will have a hybrid schedule, with 3 days onsite at our Lake County Headquarters.

    Qualifications:

    • Bachelor's degree with related health science background or quality background;
    • Minimum 4 years clinical experience or 3 years related pharma experience.

    About Us:

    AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.


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