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Manager, Global Patient Safety ICSR
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Manager, Global Patient Safety ICSR
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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Description

The Manager, Global Patient Safety (GPS) Individual Case Safety Report (ICSR) is responsible for performing triage of all safety information, providing vendor management and oversight of ICSR processing activities, and has operational responsibility of the Intake team. This individual may also have the line management responsibility of the intake team.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

  • Experienced in all ICSR workflow steps, including intake, data entry, narrative writing, case finalization and regulatory reporting
  • Work with a high degree of independence
  • Ensure compliance with applicable regulatory requirements and guidelines
  • Sound decision making skills
  • Solid written and oral communication skills

Minimum Requirements:

  • B.S. (or equivalent degree) and 4 - 5 years of relevant work experience, or
  • PharmD, M.S.N (or equivalent degree) and 3 - 5 years of relevant work experience
  • Excellent project management skills with the ability to align internal and external resources
  • Vendor management experience preferred
  • Line management experience preferred

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