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