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

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

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 [email protected].

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Drug Safety Specialist

TLDR