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Global Pharmacovigilance Medical Director

  • Job type: Permanent
  • Location: Bridgewater, New Jersey
  • Salary: Negotiable
  • Job reference: 278851/008_1555369318
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/04/2019

Global Pharmacovigilance Medical Director

Northern, New Jersey

Our client is a global bio-pharmaceutical company focusing on rare and orphan diseases and they are seeking a Global Pharmacovigilance Medical Director to join their Global Patient Safety team. With 4,000 employees globally this organization is the perfect size to afford its employees long term stability, and while having tremendous amount professional growth. This role has high visibility within the organization so this individual will have the ability to have a major impact on the success of the PV group as well as the organization as a whole.

The Global Pharmacovigilance Medical Director will have the following responsibilities:

  • Medical Review of ISCRs

  • Review, preparation and sign-off of aggregate reports (DSURs, PSURS, PBERs, etc.)

  • Lead safety signal management throughout product life-cycle including signal detection, evaluation, validation and development of risk management strategies.

  • Contribute to Corrective Action and Preventative Action Plans (CAP).

  • Communicate effectively and timely on safety and benefit/risk assessment, risk analyses, communication, mitigation, and minimization to internal and external stakeholders.

  • Response documents to inquiries from world-wide regulatory agencies

The ideal candidate will have the following skill set:

  • Education: Medical Degree, Doctorate, or international equivalent

  • 2 + years Medical PV experience

  • 3+ years clinical experience

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