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    Director - Safety Surveillance

    Novo Nordisk
    10-15 years
    Not Disclosed
    Plainsboro
    10 Jan. 3, 2025
    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, 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

    Job Title: Senior Director Safety Surveillance
    Location: Plainsboro, United States
    Job Category: Regulatory Affairs & Safety Pharmacovigilance

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    About the Department:

    Our Research & Development (R&D) teams are located in facilities across Lexington, Watertown, Cambridge, and Seattle, uniting the brightest minds in life sciences to innovate and develop medicines that improve patient outcomes. At Novo Nordisk, we focus on collaboration and partnerships across various therapeutic areas to develop differentiated products. Our R&D hub combines the speed and agility of biotech with the resources and stability of a large pharmaceutical company, creating an environment where innovation thrives.

    The Position:

    We are seeking a Senior Director, Safety Surveillance to lead the safety surveillance sub-function within our U.S. East Coast Development Hub. This role will oversee the safety strategy and deliverables for assigned programs in close collaboration with Global Safety Surveillance and cross-functional teams. You will lead a team of Global Safety Leads, Senior Global Safety Scientists, and Safety Scientists, ensuring the ongoing safety profile of assigned molecules and products is accurately assessed and communicated to both internal and external stakeholders.

    Key Responsibilities:

    Leadership & Strategic Oversight:

    • Lead the development and implementation of safety strategies and oversee the safety surveillance process for assigned molecules/products.
    • Manage the safety surveillance team, including Senior Global Safety Leads and Safety Scientists, ensuring compliance with organizational policies and procedures.
    • Oversee daily operations of the function and ensure alignment with Novo Nordisk’s strategic goals.

    Safety Surveillance & Risk Mitigation:

    • Perform ongoing surveillance of clinical and post-approval safety data, identify risks, and initiate actions to mitigate any potential safety signals.
    • Conduct periodic literature surveillance for marketed and developmental products.
    • Lead the preparation and review of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).

    Collaboration & Communication:

    • Collaborate with cross-functional teams, including Medical & Science, Clinical Operations, Regulatory Affairs, and Data Management to ensure comprehensive safety oversight.
    • Act as a representative in the Product Labelling Committee (PLC) Review Group and collaborate with regulatory authorities.
    • Communicate safety information effectively to internal stakeholders and external parties, including Healthcare Professionals (HAs), Ethics Committees (ECs), and Data Monitoring Committees (DMCs).

    Clinical Trial Safety Leadership:

    • Provide safety input to Clinical Trial Plans, Protocols, and Clinical Trial Reports.
    • Act as a safety representative in trial safety groups and provide safety leadership during Phase I trials (e.g., dose escalation decisions).
    • Ensure safety coordination with Risk-Based Monitoring activities and across global project teams.

    Qualifications:

    Education & Experience:

    • MD, PhD, or equivalent degree with 10+ years of experience in global safety surveillance, clinical development, or drug development. Alternatively, a life sciences/pharmacy/nursing degree with 15+ years of experience will be considered.
    • Proven expertise in global safety surveillance, pharmacovigilance, and clinical trial safety.

    Skills & Competencies:

    • Strong verbal and written communication skills, with the ability to lead and influence cross-functional teams.
    • Solid organizational and problem-solving abilities.
    • Ability to work under pressure while maintaining a positive attitude.
    • Extensive experience in the preparation of safety documentation and regulatory reports.

    Why Join Novo Nordisk:

    At Novo Nordisk, we value diversity and inclusion and are committed to fostering an environment where every employee is empowered to succeed. We believe in creating a culture that celebrates our differences, which leads to innovation and ultimately benefits patients around the world. Join us and contribute to groundbreaking work that will make a life-changing difference for patients.

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