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Job

Director, Pharmacovigilance Operations

  • Location

    New York City

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Experience dependent

  • Contact:

    Marin Haugo

  • Contact email:

    m.haugo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    Ref-11

  • Published:

    about 2 months ago

  • Expiry date:

    2022-05-28

  • Startdate:

    ASAP

Our client is a clinical-stage biopharmaceutical company in the CNS/Neurology space looking for a Director, of Pharmacovigilance Operations. This role is responsible for the oversight of the Pharmacovigilance (PV) Quality Management System including oversight of PV safety vendor activities, leading interactions between pharmacovigilance and other internal departments, monitoring PV quality/compliance activities, and liaising with external partners for the contractual exchange of safety information. This position requires an experienced and accomplished safety operations professional who can provide functional and technical expertise while collaborating with multiple stakeholders. This role will act as the Clinical Program Lead and engage in product planning and life cycle management. This role is hybrid, based out of New York City.

Experience

  • Oversight of safety vendor activities including the case processing of adverse events in the global safety database for investigational and approved products; reconciliation of adverse event information with partners and other parties, and the production of a variety of safety reports
  • Oversight of submissions of expedited reports to the FDA & other health authorities
  • Develop standard procedures and guidelines for safety operations
  • Participate in the creation of cross-functional Pharmacovigilance procedures 

Educational requirements

  • Bachelor’s degree is required with an Advanced degree or health care certification preferred
  • Minimum 7 years of experience in the pharmaceutical/biotechnology industry and 5 years of experience in pharmacovigilance operations