Drug Safety Specialist

Precision For Medicine; México; On-site; MXN 606,796 - 866,851; Full time

Job summary

A leading healthcare organization in Mexico is seeking a Safety Specialist to enhance safety operations. The ideal candidate will have at least 2 years of clinical trial drug safety experience and a relevant Bachelor's degree. Responsibilities include processing safety data, drafting narratives, and ensuring compliance with safety regulations. Proficiency in English is essential. The position supports professional growth in a diverse and inclusive environment.

Qualifications

• Minimum 2 years clinical trial drug safety experience.
• Professional working proficiency in English.

Responsibilities

• Process IC&S according to SOPs and project‑specific safety plans.
• Draft case narratives and generate timely regulatory reports.
• Coordinate reconciliation of safety and clinical databases.

Skills

Safety reporting requirements knowledge

Clinical safety data analysis

Narrative writing skills

Attention to detail

Case management

Education

Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent

Tools

Argus Safety Database

MedDRA

WHODrug

Job description

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 [e-mail].