Drug Safety Specialist – Clinical Trials

About the role

We are expanding our presence across Latin America and are looking for a Drug Safety Specialist to join our safety team. The role focuses on the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and post‑marketing programs.

Key responsibilities

• Process ICSRs according to SOPs and project‑specific safety plans.
• Triages and evaluate case data for completeness and regulatory reportability.
• Enter data into the Argus Safety Database, coding events, medical history, concomitant medications, and tests.
• Draft case narratives and manage query resolution until case closure.
• Generate expedited regulatory reports and coordinate safety‑clinical database reconciliation.
• Participate in audits, inspections, and project meetings.
• Maintain compliance with SOPs, GCP, ICH, GVP, and relevant regulations.

Required profile

• Minimum 2 years of clinical trial drug safety experience.
• Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent.
• Professional working proficiency in English.

Required skills

• Proficiency with Argus Safety Database.
• Experience using MedDRA and WHODrug coding dictionaries.
• Knowledge of FDA, EMA, and ICH safety regulations.
• Understanding of GCP, ICH, and GVP guidelines.