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    Head Of Patient Safety - North America Operations

    Novo Nordisk
    10+ years
    Not Disclosed
    Plainsboro
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: MD/ PhD/ PharmD/ NP 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: Head of Patient Safety - North America

    Location: Novo Nordisk, North America Operations (NAO)
    Company: Novo Nordisk

    About the Department

    The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is recognized for its diversity and collaboration. The department is integral in healthcare-provider interactions, regulatory strategy implementation, and supporting new product development through medical education and data collection. CMR is guided by a patient-centered focus, always striving to find innovative ways to improve the quality of life for patients. At Novo Nordisk, we are committed to changing lives for a living. Are you ready to make a difference?

    The Position

    As the Head of Patient Safety for North America, you will act as the safety expert to establish and manage processes, procedures, and controls to ensure compliance with all internal and external regulations in the US and Canada. Your primary responsibility will be to ensure compliance with US drug and device safety reporting regulations, Health Canada regulations, ICH guidelines, and the management of contracts with safety reporting requirements.

    Additionally, you will provide strategic leadership and expertise for Patient Safety in the North America Operations (NAO), ensuring alignment with Novo Nordisk's broader goals and objectives. You will also collaborate closely with Headquarters (HQ), Novo Nordisk, Inc. (NNI), and Novo Nordisk Canada, Inc. (NNCI) to maintain the safety profile of the company's products.

    Key Responsibilities

    Compliance & Accountability

    • Represent the Patient Safety department as an expert in cross-functional teams and external engagements.
    • Ensure Signal Management activities comply with NAO regulations and expectations of regulatory authorities (FDA and Health Canada).
    • Oversee safety assessment activities through the entire product lifecycle, from development to maintenance.
    • Direct the development of SOPs ensuring compliance with corporate and local safety needs.

    Regulatory & Safety Oversight

    • Lead FDA and Health Canada safety submissions and ensure safety reporting responsibilities are met.
    • Manage compliance with Good Manufacturing Practices (GMP) for technical complaint handling.
    • Serve as the lead SME during regulatory inspections and audits, ensuring preparedness and compliance.
    • Develop Key Performance Indicators (KPIs) for safety-related reporting and data analysis.

    Strategic Leadership & Stakeholder Engagement

    • Develop strategies and processes for continuous improvement in business productivity across departments.
    • Influence and align safety strategies with regulatory, medical, and development teams.
    • Ensure compliance with Service Level Agreements (SLAs) and Pharmacovigilance Agreements (PVAs).
    • Provide safety updates and strategic insights to management, including promotional review, labeling, and contract reviews.

    People Leadership & Development

    • Lead and manage the Patient Safety leadership team, focusing on team-building, motivation, and development.
    • Ensure that individual development plans (IDPs) are in place for all direct reports, aligned with business priorities and measurable goals.

    Physical Requirements

    • 10–20% overnight travel is required.

    Qualifications

    Education

    • Bachelor’s degree in health sciences or a related field; advanced degree (e.g., MD, PhD, PharmD, NP) preferred.

    Experience

    • 10+ years of experience in drug safety or pharmacovigilance or related fields.
    • 6+ years of people management experience, with a proven track record of mentoring and developing teams.
    • Strong knowledge of US and Canada drug safety regulations, CIOMS, and ICH guidelines.
    • Experience with Signal Detection and Pharmacovigilance databases (e.g., Argus, Cognos, Empirica).

    Skills

    • Strategic decision-making and leadership capabilities.
    • Ability to influence and collaborate with internal and external stakeholders in a matrix environment.
    • Excellent written and verbal communication skills, with the ability to impact and influence without authority.

    Equal Opportunity Employer

    Novo Nordisk is committed to fostering an inclusive and diverse workplace. We value the diverse perspectives, backgrounds, and cultures of our employees, and we are committed to providing equal opportunities for all applicants.

    For accommodation requests during the application process, please call 1-855-411-5290.

    Apply Now: Novo Nordisk Careers

    Together, we’re life-changing.

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