Added
29 days ago
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Full time
Salary
Salary not provided
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Related skills

ich guidelines gvp meddra regulatory compliance whodrug

📋 Description

  • Process ICSRs per SOPs and safety plans
  • Triages ICSRs; evaluates data for completeness and reportability
  • Enter data into Argus Safety Database
  • Code events, medical history, concomitant meds and tests
  • Draft case narratives
  • Distribute expedited and periodic safety reports

🎯 Requirements

  • Minimum 2 years in clinical trial drug safety in Pharma/CRO
  • Bachelor’s or entry-level degree in Pharmacy or Nursing preferred
  • Experience with Oracle Argus Safety Database
  • Working knowledge of MedDRA and WHODrug
  • Knowledge of FDA safety regs, EMA/MHRA and ICH guidelines
  • Immuno-oncology and Advanced Therapy Medicinal Products experience a plus
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