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    Senior Director, Head Of Medical Review

    Bristol Myers Squibb
    7+ years
    Not Disclosed
    Madison Princeton Junction
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: MD or equivalent; board certification preferred. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Position: Head of Medical Safety Review
    Location: Princeton, NJ & Madison (Giralda), NJ, USA
    Time Type: Full-time
    Job Requisition ID: R1587478

    Overview:

    The role involves leading a global team of up to 80 Medical Safety Review Physicians to ensure excellence in pharmacovigilance, adverse event monitoring, and regulatory compliance for Bristol Myers Squibb's (BMS) products. The position also focuses on innovation, process improvement, and collaboration across global teams.

    Key Responsibilities:

    Strategic Leadership:

    • Develop and implement strategies to enhance medical review and pharmacovigilance operations.
    • Drive innovation, automation, and efficiency in safety reporting and monitoring processes.

    Management & Compliance:

    • Oversee Therapeutic Area Heads and ensure consistent global work practices.
    • Ensure compliance with global regulatory requirements, including timely adverse event reporting.
    • Represent the department during audits, inspections, and regulatory engagements.

    Medical Review:

    • Oversee adverse event case assessments, ensuring quality and identifying potential safety signals.
    • Guide reviews of critical events (e.g., SUSARs, AEs of interest, DILI).

    Collaboration & Innovation:

    • Partner with internal and external stakeholders to enhance safety profiles and regulatory submissions.
    • Lead quality monitoring and vendor oversight to ensure consistency and excellence.

    Requirements:

    Education & Experience:

    • MD or equivalent; board certification preferred.
    • Minimum 7 years of combined relevant experience (2+ years clinical, 5+ years pharmaceutical industry).
    • Experience in a global matrix organization and vendor management is advantageous.

    Competencies:

    • Expertise in pharmacovigilance, regulatory guidelines (ICH, GCP), and safety databases (e.g., ARGUS, ArisG).
    • Proven leadership and problem-solving skills.
    • Strong communication, interpersonal, and time management skills.

    Technical Skills:

    • Knowledge of MedDRA, WHODrug, and adverse event reporting systems.
    • Ability to manage complex medical and regulatory issues efficiently.

    About BMS:

    At Bristol Myers Squibb, employees contribute to transformative work, leveraging innovative approaches to improve patients' lives. The company emphasizes diversity, flexibility, and professional growth opportunities in an inclusive environment.

    For more details, visit careers.bms.com.

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