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Drug Safety Specialist

2 hours, 40 minutes ago
Mexico, Argentina, Brazil, Chile, Colombia, Peru
Full-time
Junior
Operations Specialist
Operations
GCP
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 24

Description

  • Process individual case safety reports (ICSRs) according to SOPs and project-specific safety plans.
  • Triages ICSRs and evaluate case data for completeness and regulatory reportability.
  • Enter safety case data into the Argus Safety Database.
  • Code events, medical history, concomitant medications, and tests.
  • Draft case narratives and resolve queries through follow-up to completion.
  • Generate timely expedited regulatory reports and ensure required safety report distribution.
  • Coordinate reconciliation between safety and clinical databases.
  • Submit documents to the TMF/PV System MF and maintain inspection-ready records.
  • 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, and WHODrug.
  • Knowledge of FDA, EMA, and 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 and ability to manage multiple cases and deadlines.

Benefits

  • Equal Opportunity Employer status with non-discriminatory hiring practices.
  • Reasonable accommodation available for applicants with disabilities.
  • Privacy policy and California applicant privacy notice provided.
  • Formal interview process and verified recruiting communication to reduce fraud risk.

Interested in this position?

Apply directly on the company website

Apply Now

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