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Sr. Medical Director Pharmacovigilance

Company: ASM, Associates in Scientific Management
Location: New York
Posted on: November 11, 2019

Job Description:

NJ-Sr. Medical Director PVThis growing global pharmaceutical company with US offices in the Chatham, NJ area is seeking an MD who is a seasoned Pharmacovigilance specialist who knows how to submit the necessary documents to the various regulatory agencies but also how to interpret, and advice senior management. The Drug Safety expert will have accountability for safety surveillance, risk management, risk communication, the generation and review of aggregate reports, risk management plans (including REMS) and other safety documents for all project and products.
The PV professional will support Pharmacovigilance Operations (PVO) by providing medical evaluation of Individual Case Safety Reports (ICSRs) enabling timely reporting; and will collaborate with global colleagues to develop strategic roadmaps for managing the benefit risk profile of assigned products.
Professional Skills

  • MD or DO from accredited institution of Medical Education (board certified preferred; board eligible or foreign equivalent) with a minimum of 3 years of clinical experience.
  • 12 plus years of pharma industry related experience with at least 7 years of Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting.
  • Ability to manage urgent and unexpected crisis safety situations/alarms and to identify issues and take appropriate actions.
  • Without question, the candidate should have strategic and technical expertise with excellent written and verbal communication skills. Must thrive in a creative, collaborative and engaging environment.

    Please Contact:
    Janice Walsh ASM

Keywords: ASM, Associates in Scientific Management, New York , Sr. Medical Director Pharmacovigilance, Executive , New York, New York

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