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Drug Safety Specialist

2 hours, 25 minutes ago
Mexico, Argentina, Brazil, Chile, Colombia, Peru
Full-time
Junior
Operations Specialist
Operations
GCP
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 59

Description

  • Process individual case safety reports (ICSRs) according to SOPs and project-specific safety plans.
  • Triage ICSRs and assess data for completeness and regulatory reportability.
  • Enter case data into the Argus Safety Database.
  • Code events, medical history, concomitant medications, and tests.
  • Draft case narratives and resolve queries through follow-up until complete.
  • Generate timely expedited regulatory reports.
  • Coordinate reconciliation between safety and clinical databases.
  • Ensure required safety reports are distributed and submitted to the TMF/PV system.
  • Participate in audits, inspections, department meetings, and project meetings.
  • Maintain compliance with SOPs, GCP, ICH, GVP, and applicable regulations.

Requirements

  • Minimum 2 years of clinical trial drug safety experience.
  • Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent.
  • Experience with Argus Safety Database, MedDRA, WHODrug, and FDA/EMA/ICH safety regulations.
  • Professional working proficiency in English.
  • Early phase oncology experience preferred.
  • Strong knowledge of safety reporting requirements and guidelines.
  • Ability to analyze and evaluate clinical safety data.
  • Strong written communication and narrative writing skills.
  • Strong attention to detail.
  • Ability to manage multiple cases and deadlines.

Benefits

  • Equal Opportunity Employer status with non-discriminatory hiring practices.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and CA privacy notice provided for applicant data handling.
  • Formal interview process before any job offer to help protect candidates from fraudulent offers.

Interested in this position?

Apply directly on the company website

Apply Now

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