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    Executive Medical Director/Vice President, Drug Safety And Pharmacovigilance Physician

    Pharma People
    7+ years
    $300,000/yr - $420,000/yr
    Princeton Junction
    10 July 10, 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

    Position Information:

    • Title: Executive Medical Director/Vice President, Drug Safety and Pharmacovigilance Physician
    • Company: Leading High Growth Oncology-focused Biotech
    • Department: Pharmacovigilance
    • Reports To: Not specified
    • Location: Not specified

    Role Overview:

    The Executive Medical Director/Vice President, Drug Safety and Pharmacovigilance Physician will serve as a critical medical and data analytical expert for assigned investigational products within Oncology. This role focuses on the development and implementation of proactive risk management strategies, ensuring patient safety, and maintaining the highest quality and ethical standards.

    Key Responsibilities:

    1. Risk Management:

      • Act as the subject matter expert responsible for developing proactive risk management strategies for a portfolio of core strategic investigational products within Oncology.
      • Create and implement risk management strategies for assigned products.

    2. Safety Analysis:

      • Analyze and produce safety evidence and perform safety & efficacy analyses to support the overall plans for the team.
      • Provide expert medical input to regulatory documents.
      • Interpret clinical trial safety data for clinical trial reports and submission documents.

    3. Patient Safety:

      • Ensure patient safety while adhering to the highest quality and ethical standards.

    4. Representation:

      • Represent Pharmacovigilance data to internal and external multidisciplinary committees & bodies.

    Qualifications:

    • Education:

      • MD required.

    • Experience:

      • Extensive experience in Pharmacovigilance at a pharmaceutical company.
      • Experience working on Global Clinical Trials, clinical development, and post-marketing safety.
      • Exposure to therapeutic areas, particularly Oncology, is preferred.

    • Skills:

      • In-depth understanding of research methods and procedures.
      • Strong background in epidemiological theory, methods, or health informatics is a plus.
      • Excellent verbal and written communication skills.
      • Strong organizational, project management, and leadership skills.
      • Attention to detail and critical thinking ability required.

    About the Company:

    Our client is a leading High Growth Oncology-focused Biotech company expanding their Pharmacovigilance team. The company is dedicated to advancing innovative treatments in Oncology, ensuring patient safety, and maintaining high ethical standards.

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