Location
são paulo
Posted
June 19, 2026
Commute
Local Area
Local Opportunity Near You!
This job is in your area. Enjoy a short commute and work close to home.
Job Description
Drug Safety Specialist / Senior Specialist – Job Summary We are looking for a Sr Drug Safety Specialist based in Brazil to work remote and support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post‑marketing sources, ensuring timely and compliant submissions to global regulatory authorities. Key Responsibilities Process ICSRs, including case validation, day‑zero determination, review of source documents, and escalation of special safety situations. Perform medical coding, narrative writing, listedness assessments, follow‑up determination, and Analysis of Similar Events. Ensure workflow compliance by reviewing safety database timelines and case progression. Conduct reconciliation between clinical trial databases and safety systems. Execute due diligence activities, including query distribution and follow‑up with external reporters. Contribute to compliance, productivity, and quality performance metrics. Support continuous improvement initia...