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 Mexico, Brazil, Argentina, Colombia, Chile, and Peru.
• • Day-to-day duties include processing ICSRs per SOPs, triaging cases for completeness and regulatory reportability, entering data into the Argus Safety Database, coding medical events and concomitant medications, drafting case narratives, resolving queries, generating expedited regulatory reports, coordinating database reconciliations, ensuring safety report distribution, participating in audits, and maintaining compliance with GCP, ICH, GVP, and SOPs.
• • PFM Asset Management (operating under Precision Medicine Group) is expanding its drug safety capabilities in key Latin American markets and seeks a detail-oriented professional to support global pharmacovigilance operations in a remote, collaborative environment.
• • The role offers the opportunity to deepen expertise in global drug safety regulations, gain hands-on experience with industry-standard safety databases (Argus, MedDRA, WHODrug), contribute to audit readiness, and advance professionally within a growing global safety team focused on oncology and early-phase clinical trials.