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    Associate Director, Global Drug Safety & Pharmacovigilance Scientist

    Genmab
    5+ years
    Not Disclosed
    Princeton Junction
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, 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:

    Associate Director, Drug Safety and Pharmacovigilance Scientist

    Location:

    Princeton, NJ

    Company Overview:

    Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody products and pioneering therapies for cancer and serious diseases. With a focus on scientific excellence, Genmab has built a collaborative and impact-driven team that is committed to transforming patient care.

    Job Description:

    As an Associate Director, Drug Safety and Pharmacovigilance Scientist, you will join Genmab's Global Drug Safety and Pharmacovigilance department. You will be responsible for drug-related safety activities, collaborating closely with safety colleagues and cross-functional teams. This position involves global responsibilities, interacting with regulatory authorities and stakeholders across Genmab’s international locations.

    Key Responsibilities:

    • Adverse Event Reports:
      • Perform safety reviews of Adverse Event reports for Genmab products.
      • Conduct ongoing surveillance, including signal detection and evaluation, of clinical trials and post-marketing safety data.
    • Safety Contact:
      • Serve as the primary safety contact for other departments, ensuring timely handling of safety issues.
    • Document Review and Input:
      • Provide safety review and input for trial protocols, eCRFs/CRFs, TMFs, Investigator’s Brochures, and Subject Informed Consent.
    • Safety Documentation:
      • Contribute to the development of safety-related documents throughout the product lifecycle, including Safety Assessment Reports, Aggregate Safety Reports, and responses to safety information requests.
    • Committee Activities:
      • Contribute to Safety Committee activities and Data Monitoring Committees (DMCs).
    • Training:
      • Conduct safety training for Genmab employees, CROs, investigators, and relevant site personnel.
    • Project Groups:
      • Participate in multidisciplinary project groups, including membership in the Clinical Management Team (CMT) for assigned products.
    • Regulatory Compliance:
      • Ensure compliance with regulatory guidelines and internal processes, participating in audit and inspection activities as required.
    • External Collaboration:
      • Collaborate with external experts, partners, and safety CROs, ensuring regulatory compliance and managing safety-related tasks.

    Requirements:

    • Education:
      • Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD).
    • Experience:
      • Minimum 5+ years of pharmaceutical industry experience in drug safety and pharmacovigilance.
      • Experience in oncology and/or first human trials is preferred.
      • Experience authoring safety signal assessment reports, DSUR, PBRER, RMP, and RSI.
    • Skills:
      • Proficient in signal detection processes and managing safety information.
      • Knowledge of FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
      • Experience with pharmacovigilance databases and MedDRA coding, preferably Argus Safety Database.
      • Excellent communication, leadership, and interpersonal skills.
      • Ability to work in a fast-paced, dynamic environment.

    Compensation:

    • Salary Range: $142,500.00 - $237,500.00 (based on skills, qualifications, experience, and location).
    • Additional Compensation: Eligibility for bonuses and other forms of compensation.

    About Genmab:

    Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. Genmab is dedicated to diversity, equity, and inclusion, fostering a workplace that values diverse experiences, backgrounds, and perspectives.

    Application:

    To apply, visit Genmab Careers and follow the application instructions. For applicants requiring accessibility assistance, please contact Genmab’s HR department for support.

    Join Genmab and contribute to developing innovative therapies that transform patient lives and the future of cancer treatment.

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