Drug Safety Specialist

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!

The Safety Specialist is an integral part of the safety team and performs all aspects of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or post‑marketing programs.

Main Duties & Responsibilities:

• Process ICSRs according to SOPs and project-specific safety plans
• Triages ICSRs, evaluates data for completeness and regulatory reportability
• Enter data into Argus Safety Database
• Code events, medical history, concomitant meds, and tests
• Draft case narratives
• Query resolution and follow‑up until complete
• Generate timely expedited regulatory reports
• Coordinate reconciliation of safety and clinical databases
• Ensure required safety reports distribution
• Participate in audits/inspections
• Submit documents to TMF/PV System MF
• Maintain compliance with SOPs, GCP, ICH, GVP, regulations
• Attend department meetings
• Participate in project meetings
• Other duties as assigned

Education and Experience:

Minimum Education & Experience:

• Minimum 2 years clinical trial drug safety experience; Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent. Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulations
• Professional working proficiency in English

Preferred Education & Experience:

• Early phase oncology experience preferred

Knowledge, Skills, and Competencies:

• Strong knowledge of safety reporting requirements and guidelines
• Ability to analyze and evaluate clinical safety data
• Strong written communication and narrative writing skills
• Experience with Argus, MedDRA, WHODrug
• Strong attention to detail
• Ability to manage multiple cases and deadlines