Pharmacovigilance Expert Remote
Overview
We seek Pharmacovigilance Expert to enhance AI systems by reviewing safety documentation. You will improve next generation AI tools through analysis of pharmacovigilance records. No AI background needed. Your expertise matters most.
What You'll Do7
- 1Author and review evaluation tasks using DSURs PSURs PBRER safety data
- 2Assess safety findings signal evaluations benefit risk conclusions
- 3Review reports for ICH E2F ICH E2C(R2) and GVP compliance
- 4Analyze aggregate safety data reconcile case counts figures inconsistencies
- 5Evaluate safety conclusions based on new data events regulations
- 6Provide structured written feedback rationales for AI tools
- 7Ensure accuracy completeness quality regulatory safety documentation
Requirements11
- 1Pharmacovigilance Drug Safety Report Authoring DSUR PSUR PBRER Review
- 2ICH E2F ICH E2C(R2) Compliance GVP Guidelines
- 3Aggregate Safety Data Analysis Signal Management
- 4Benefit Risk Assessment MedDRA Coding Seriousness Causality
- 5Expectedness Determination Data Reconciliation Regulatory Documentation
- 6Attention to Detail
- 7Preferred: 5+ years pharmacovigilance experience sponsor CRO consulting
- 8Strong knowledge ICH E2F ICH E2C(R2) guidelines
- 9Experience reconciling safety data case level information
- 10Advanced degree life sciences pharmacy nursing medicine PharmD MD MSc
- 11Clinical development safety post marketing surveillance QPPV deputy roles
Salary Insight
$146 - $166k per year
Location
Required Skills
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