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!
Main Duties & Responsibilities
Process IC&S; according to SOPs and project‐specific safety plans
Triages IC&S;, 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
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
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📌 Drug Safety Specialist (México)
🏢 Precision For Medicine
📍 México