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    Director, Global Drug Safety & Pharmacovigilance Physician

    Genmab
    12+ years
    $170,625.00---$284,375.00
    Princeton Junction
    12 May 17, 2024
    Job Description
    Job Type: Full Time Education: MD Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director, GDS&PV Physician

    Company: Genmab

    Location: Flexible; includes Copenhagen, Denmark; Utrecht, the Netherlands; Princeton, New Jersey, USA; and Tokyo, Japan.

    Employment Type: Full-time

    Salary Range: $170,625.00 - $284,375.00 (For US-based candidates)

    About the Company: Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. With a robust pipeline and strategic partnerships, Genmab is focused on pioneering cancer treatments and addressing serious diseases. Established in 1999, Genmab has offices in Copenhagen, Utrecht, Princeton, and Tokyo.

    Job Summary: The Director, GDS&PV Physician will lead major safety-related activities and ensure the global safety strategy for Genmab products, primarily investigational. This role involves cross-functional collaboration, regulatory compliance, and mentoring junior colleagues.

    Key Responsibilities:

    • Lead pre- and post-marketing safety activities, including signal and risk management.
    • Collaborate with cross-functional teams for safety assessment and communication.
    • Oversee safety issue handling and risk mitigation.
    • Provide inputs for trial protocols, clinical trial reports, and related documents.
    • Prepare regulatory documentation, including safety summaries.
    • Manage forums like Data Monitoring Committees and Safety Committees.
    • Train and mentor team members on safety and PV processes.
    • Engage with internal and external stakeholders regarding safety and regulatory issues.
    • Support the Clinical Research Department with case processing.
    • Participate in training and inspections related to PV processes.

    Qualifications:

    • MD required.
    • Minimum 12+ years in drug safety/pharmacovigilance, preferably in oncology.
    • Experience with PV audits and regulatory authority inspections.
    • Knowledge of global PV regulations, MedDRA, WHODrug coding, and safety databases (ARISg, ARGUS).
    • Proven leadership and mentoring skills.
    • Strong analytical and communication skills.

    Skills:

    • Proficient in safety databases and electronic data capture systems.
    • Ability to manage multiple projects and deadlines.
    • Excellent written and verbal communication.
    • Strong team collaboration and mentoring capabilities.

    Work Environment: Genmab offers an agile working environment with a balance of remote and in-office work. The offices are designed as open, community-based spaces to foster collaboration and innovation.

    Diversity Commitment: Genmab is committed to diversity, equity, and inclusion. All applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, or genetic information.

    Application Process: Please visit Genmab Careers to apply and review our privacy policy for handling your data.

    Additional Information:

    • For positions in the Netherlands, initial employment contracts are fixed-term for one year, with potential renewal for an indefinite term based on performance and business conditions.
    • Benefits include medical, dental, vision, and 401k.

    About You:

    • Passionate about transforming patient lives through innovative treatments.
    • Rigorous and excellence-driven in problem-solving.
    • Collaborative team player with diverse backgrounds.
    • Determined to achieve and enable the best work.
    • Innovative and adaptable in a dynamic company.
    • Enjoys working hard and having fun.

    Join Genmab: If you are ready to be part of a groundbreaking team at the intersection of healthcare and technology, apply now and help us revolutionize cancer treatment and serious disease therapies.

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