Drug Safety Specialist

📋 Description

• • The Drug Safety Specialist is an integral part of the safety team, responsible for the collection, processing, and reporting of individual case safety reports (ICSRs) for clinical trials and post-marketing programs across Latin America, ensuring compliance with global pharmacovigilance standards.
• • Day-to-day duties include processing ICSRs per SOPs, triaging cases for completeness and reportability, entering data into the Argus Safety Database, coding medical events and medications using MedDRA and WHODrug, drafting case narratives, resolving queries, generating expedited regulatory reports, coordinating safety and clinical database reconciliation, maintaining TMF/PV system documentation, and participating in audits and project meetings.
• • Precision Medicine Group is expanding its safety operations in Mexico, Brazil, Argentina, Colombia, Chile, and Peru, offering a remote opportunity to contribute to drug safety in clinical research within a growing, global organization committed to precision medicine and patient safety.
• • In this role, you will deepen your expertise in global safety regulations (GCP, ICH, GVP, FDA/EMA), gain hands-on experience with Argus Safety Database and medical coding systems, strengthen your scientific writing and analytical skills, and grow professionally within a collaborative safety team supporting critical clinical development programs.