Drug Safety Specialist

About the role

We are expanding our pharmacovigilance capabilities across Latin America and are looking for a Drug Safety Specialist to join our safety team. The role involves managing individual case safety reports (ICSRs) for clinical trials and post‑marketing programs, ensuring compliance with global regulations.

Key responsibilities

• Process and triage ICSRs according to SOPs and project‑specific safety plans.
• Enter data into the Argus Safety database, coding events, medical history, concomitant medications and laboratory tests.
• Draft case narratives and resolve queries until case closure.
• Generate expedited regulatory reports and coordinate safety‑clinical database reconciliation.
• Participate in audits, inspections and project meetings, and maintain documentation in TMF/PV systems.
• Ensure compliance with GCP, ICH, GVP and local regulatory requirements.

Required profile

• Minimum 2 years experience in clinical trial drug safety.
• Bachelor’s degree in Pharmacy, Nursing, Life Sciences or equivalent.
• Professional working proficiency in English.
• Early‑phase oncology experience is a plus.

Required skills

• Proficiency with Argus Safety Database.
• Knowledge of MedDRA and WHODrug coding dictionaries.
• Familiarity with FDA, EMA and ICH safety regulations.
• Strong attention to detail and ability to manage multiple cases and deadlines.