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1 day ago
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Full time
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gxp ich pharmacovigilance fda meddra

📋 Description

  • Oversee clinical safety and pharmacovigilance activities across projects.
  • Serve as central resource for safety decision-making and process improvement.
  • Partner with sponsors, vendors, study teams, and internal stakeholders on safety tools and
  • Manage SAE/SUSAR case activities from intake through regulatory reporting.
  • Lead safety database assessment, setup, and ongoing management.
  • Provide training and mentorship to Safety Specialists and team members.

🎯 Requirements

  • Bachelor’s degree in a relevant field.
  • 10+ years of clinical safety experience.
  • 5+ years of pharmacovigilance experience.
  • Hands-on experience with global safety databases, SAE processing, and safety report generation.
  • Strong knowledge of MedDRA and WHODrug coding systems.
  • Working knowledge of FDA safety regulations, ICH guidelines, and global pharmacovigilance

🎁 Benefits

  • Competitive salary: $110,700 – $166,100 USD.
  • Eligibility for discretionary annual bonus opportunities.
  • Comprehensive health insurance, retirement savings, life and disability coverage.
  • Paid time off, parental leave, remote work flexibility.
  • Opportunities to contribute to innovative clinical research programs.
  • Professional growth and development opportunities.
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