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Drug Safety Specialist

Precisionmedicinegroup
9 days ago
Full-time
Remote
Worldwide
Remote Healthcare

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!

 

The Safety Specialist is an integral part of the safety team and performs all aspects of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or postmarketing programs.

 

Main Duties & Responsibilities:

 

  • Process ICSRs according to SOPs and project-specific safety plans
  • Triages ICSRs, evaluates data for completeness and regulatory reportability
  • Enter data into Argus Safety Database
  • Code events, medical history, concomitant meds, and tests
  • Draft case narratives
  • Query resolution and followup until complete