Related skills
argus meddra spotfire veevasafety dsurπ 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
π― 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
π Benefits
- Annual bonus
- Equity compensation
- Comprehensive benefits package
- Opportunity to grow with a fast-paced PV function
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