Drug Safety Specialist

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 post‑marketing programs.

• Process ICSSRs according to SOPs and project‑specific safety plans
• Triage ICSSRs, evaluate 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 follow‑up until complete
• Generate timely expedited regulatory reports
• Coordinate reconciliation of safety and clinical databases
• Ensure required safety reports distribution
• Participate...