Added
4 days ago
Type
Full time
Salary
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argus meddra spotfire veevasafety dsur

πŸ“‹ Description

  • Assess and interpret safety data from multiple sources for assigned products
  • Perform aggregate data review, signal detection, and evaluation
  • Lead internal cross-functional Safety Management Teams and meetings
  • Partner with Clinical, Regulatory, Medical, Biostats and external vendors for PV
  • Lead development/maintain Reference Safety Information (RSI)
  • Contribute to clinical/regulatory documents like IBs and study protocols

🎯 Requirements

  • Advanced clinical degree (MD/DO/NP/PA) required
  • Minimum of 8 years in pharmacovigilance with 4+ years in safety science roles
  • Experience in biotech or small-to-mid-size pharma environment
  • Deep knowledge of global safety regulations and ICH guidelines
  • Excellent written and verbal communication; distill complex data
  • Experience with Argus, VeevaSafety, MedDRA, AoSE, or DSURs

🎁 Benefits

  • Annual bonus
  • Equity compensation
  • Comprehensive benefits package
  • Opportunity to grow with a fast-paced PV function
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