Pharmacovigilance Expert Remote
Overview
We seek Pharmacovigilance Expert to enhance AI systems by reviewing drug safety documentation. This remote contractor role focuses on improving next generation AI tools through expert analysis.
What You'll Do7
- 1Author and review evaluation tasks using DSURs PSURs PBRER safety data case level records
- 2Assess safety findings signal evaluations benefit risk conclusions for accuracy
- 3Review reports for compliance with ICH E2F ICH E2C R2 and GVP guidelines
- 4Analyze aggregate safety data reconcile case counts figures inconsistencies
- 5Evaluate safety conclusions based on new data events regulatory requirements
- 6Provide structured written feedback rationales supporting AI driven tools
- 7Ensure accuracy completeness quality of regulatory safety documentation
Requirements6
- 1Pharmacovigilance Drug Safety Report Authoring DSUR PSUR PBRER
- 2ICH E2F ICH E2C R2 Compliance GVP Guidelines
- 3Aggregate Safety Data Analysis Signal Management
- 4MedDRA Coding Seriousness Causality Assessment
- 5Expectedness Determination Data Reconciliation Regulatory Documentation
- 6Attention to Detail
Salary Insight
$146 - $166k per year
Location
Required Skills
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