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    Group Medical Director, Product Safety Teams

    Abbvie
    5-7 years
    Not Disclosed
    Remote, USA
    10 July 29, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About AbbVie:

    AbbVie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and tackle the medical challenges of tomorrow. We aim to make a significant impact on people's lives across various key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as through our Allergan Aesthetics portfolio. For more information about AbbVie, please visit our website at www.abbvie.com. Follow us on Twitter, Facebook, Instagram, YouTube, and LinkedIn @abbvie.

    Job Description

    Purpose:

    The role involves managing Associate Medical Directors, Medical Directors, and Senior Medical Directors. The position leads Product Safety Teams (PST), supports one or more products as the PST Lead, and ensures the safety of these products throughout their lifecycle, including surveillance, signal detection, validation, and assessment. The role also involves interpreting pharmacovigilance regulations and supporting all patient safety activities.

    Responsibilities:

    • Utilize pharmacology, chemistry, and non-clinical toxicology knowledge to conduct safety surveillance.
    • Oversee safety surveillance for pharmaceutical, biological, and drug-device combined products.
    • Develop and strategize key pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans.
    • Apply current regulatory guidance to safety surveillance and PV document authorship.
    • Analyze and interpret aggregate safety data and communicate findings to cross-functional teams.
    • Write, review, and provide input on technical documents.
    • Lead the strategy for periodic reports (e.g., PSURs, PADERs).
    • Oversee safety surveillance and pharmacovigilance activities for clinical trials and post-marketing.
    • Implement risk management strategies for assigned products.
    • Engage, inspire, coach, and mentor team members and colleagues.
    • Manage other Associate Medical Directors, Medical Directors, and Senior Medical Directors, including performance and talent management.
    • Coordinate and oversee safety-related activities at a product level across multiple indications or related products, ensuring a cohesive product safety strategy.

    Significant Work Activities:

    • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).
    • Frequent to continuous computer usage (greater than or equal to 50% of the workday).

    Location: This role can be based anywhere in the United States, Canada, UK, or Europe.

    Qualifications:

    • MD/DO with 2+ years of residency and patient management experience.
    • Minimum of 5-7 years of experience in drug safety or a related discipline in the pharmaceutical industry.
    • Strong skills in analyzing clinical data and epidemiological information.
    • Effective presentation of recommendations/opinions in group settings, both internally and externally.
    • Experience writing, reviewing, and providing input on technical documents.
    • Ability to lead and work collaboratively in cross-functional teams.
    • Fluency in English, both written and oral.
    • Capable of making independent decisions and working effectively in situations of uncertainty and complexity, with strong multitasking abilities.
    • Relevant clinical development or PV experience in Immunology is preferred.
    • Commitment to training and developing junior staff, ensuring they work with an appropriate level of autonomy.

    Additional Information:

    The compensation range described below reflects the potential base pay for this role, which may vary depending on geographic location and other factors. The range may be adjusted in the future.

    AbbVie offers a comprehensive benefits package, including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan for eligible employees. This position is also eligible for participation in our short-term and long-term incentive programs.

    Equal Opportunity Employment:

    AbbVie is an equal opportunity employer committed to integrity, innovation, transforming lives, community service, and embracing diversity and inclusion. We employ qualified individuals based on their abilities without discrimination based on race, color, religion, national origin, age, sex (including pregnancy), disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, veteran status, or any other legally protected status. For more information, visit our Equal Employment Opportunity page.

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