Opportunity Description
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
- Other d...
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