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Vertex Pharmaceuticals logo

Associate Director, Global Patient Safety (GPS) Individual Case Safety Report (ICSR) Therapeutic Area (TA) Lead

Vertex Pharmaceuticals · Boston, MA

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SafetyFull-time$164k–$246kCompany career page

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Role summary

Associate Director leading global Individual Case Safety Report (ICSR) processing and external vendor management within a specified therapeutic area. Oversees pharmacovigilance operations, ensures regulatory compliance, and manages cross-functional initiatives at Vertex Pharmaceuticals in Boston.

What they're looking for

  • Bachelor's degree in life sciences or allied health with 8+ years direct clinical and post-marketing pharmacovigilance experience
  • 3-5 years external partner and vendor/outsourcing management experience
  • Hands-on expertise in all operational aspects of ICSR processing and reporting
  • Strong project management skills and ability to align internal and external resources
  • Excellent written, verbal, and presentation communication skills
  • Line management experience preferred
  • Ability to work autonomously and constructively in fast-paced environments

What you'll be doing

  • Lead therapeutic area ICSR operations and collaborate with other TA Leads on process harmonization and vendor oversight
  • Develop and implement innovative best practices for ICSR processes including automation and artificial intelligence implementation
  • Mentor and guide staff on pharmacovigilance aspects, clinical trial processing, and regulatory submissions
  • Serve as subject matter expert for audits, inspections, and health authority inquiries with verbal and written responses
  • Champion high-performance culture, provide performance feedback, and escalate operational challenges with proposed solutions

Privacy & handoff

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Date posted4 days ago
Last source check1 day ago
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