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Clinical Drug Safety associate

Chicago, IL

A growing pharmaceutical is looking for a Drug Safety Specialist to provide support as a member of the Safety Operations team within Global Pharma. May perform initial triage of source documents for duplicate check within the Global Safety Database, case priority, Awareness Date, and closure/submission timeline.

  • Review source documents for accuracy of triage assessment to include case priority, Awareness Date and internal and external completion/submission dates
  • Perform initial safety review of adverse events to determine seriousness, expectedness, reporter’s causality, and overall event resolution.
  • Ensure that the correct suspect drug was selected within the GSD
  • Write summaries all relevant medical information for individual case safety reports
  • Interface with other groups (e.g. Quality, Regulatory, IT, Legal, business units, etc)
Preferred candidates will have the following:
  • BS in biology, Health sciences, Nursing or other related sciences 
  • Demonstrated experience in Pharmaceutical industry 
  • 2 years experience with regulatory is preferred 
  • 4-6 years of hospital or patient care experience
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