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FSP Senior Safety Specialist

Thermo Fisher Scientific · Remote

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Role summary

Thermo Fisher Scientific seeks a Senior Safety Specialist to oversee pharmacovigilance operations, including adverse event monitoring, database management, and regulatory reporting. The remote role involves coordinating with internal teams and external vendors to ensure compliant safety data collection and analysis.

What they're looking for

  • Bachelor's or Master's degree in nursing, healthcare, or life sciences
  • 3–5 years global pharmacovigilance and drug safety experience (EU/US)
  • Advanced knowledge of medical terminology and relevant regulations
  • Proficiency with safety database systems such as ARGUS or ArisG
  • MedDRA coding experience and strong Microsoft Office skills
  • Fluent written and spoken English

What you'll be doing

  • Monitor GPS mailboxes and manage individual case safety reports with vendors
  • Review and ensure completeness and quality of ICSRs, listings, and figures
  • Reconcile adverse event data across post-marketing and clinical trial databases
  • Support generation of aggregate safety reports including DSURs and PSURs
  • Collaborate with clinical, medical, regulatory, and external stakeholders on safety information

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Date posted1 day ago
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