Jobs

    Sr Medical Director - Maryland, United States - Allergan

    Allergan
    Allergan Maryland, United States

    1 week ago

    Default job background
    Description

    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.

    We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

    For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

    Serve as Indication Product Safety Lead for one or more products or product indications under the direction of the Therapeutic Area (TA) Lead and Global TA.

    Ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
    Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
    Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products

    Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, 15 day aggregate reports.

    Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents
    Analyze, interpret, and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management
    Independently write, review, and provide input on technical documents
    Oversight and responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports (e.g. Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents
    Responsible for implementing risk management strategies for assigned product
    Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
    Master Public Health is preferred in addition to MD / DO, not required
    ~- 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
    ~ Effectively analyze and guide analysis of clinical data and epidemiological information
    ~ Write, review and provide input on technical documents
    ~ Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

    We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligible employees.

    This job is eligible to participate in our short-term incentive programs.

    AbbVie 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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