Drug Safety Specialist

Precision for Medicine is expanding capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. We’re hiring a Safety Specialist to join our growing team. The role is an integral part of the safety team, performing all aspects of collection, processing, and reporting of individual case safety reports (ICSRs) for clinical trials and post-marketing programs.

The Safety Specialist processes ICSRs according to SOPs and project-specific safety plans. They triage ICSRs, evaluate data for completeness and regulatory reportability, enter data into Argus Safety Database, code events, medical history, concomitant meds, and tests. They also draft case narratives and handle query resolution with follow-up until complete.

Daily tasks include generating timely expedited regulatory reports, coordinating reconciliation of safety and clinical databases, and ensuring required safety reports distribution. The specialist participates in audits and inspections, submits documents to TMF/PV System MF, and maintains compliance with SOPs, GCP, ICH, GVP, and regulations. They attend department and project meetings.

Joining the growing safety team offers involvement in diverse clinical trials and post-marketing programs. Preferred experience in early phase oncology enhances opportunities. Other duties as assigned support ongoing expansion in Latin America.