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Regulatory Requirements
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
Education and 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
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
Precision Medicine Group
Precision Medicine Group is expanding its capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. They are an Equal Opportunity Employer that values diversity and inclusivity.