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!

Main Duties & Responsibilities

• Process IC&S according to SOPs and project‑specific safety plans
• Triages IC&S, 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 follow‑up until complete
• Generate timely expedited regulatory reports
• Coordinate reconciliation of safety and clinical databases
• Ensure required safety reports distribution
• Participate in audits/inspections
• Submit documents to TMF/PV System MF
• Maintain compliance with SOPs, GCP, ICH, GVP, regulations
• Attend department meetings
• Participate in project meetings
• Ot...