Added
23 days ago
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Type
Full time
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Salary not provided
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gcp ich pharmacovigilance argus meddra

📋 Description

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

🎯 Requirements

  • 2+ years clinical trial drug safety experience
  • Bachelor's degree in Pharmacy, Nursing, Life Science, or equivalent
  • Experience with Argus Safety Database
  • Proficiency in MedDRA and WHODrug
  • Knowledge of FDA/EMA/ICH safety regulations
  • English language proficiency
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