Pharmacovigilance Expert Remote
Overview
We seek Pharmacovigilance Expert to enhance AI systems through drug safety expertise. This contractor role involves improving next generation AI by reviewing documentation and regulatory content. Your pharmacovigilance analytical skills and commitment to data quality drive success.
What You'll Do7
- 1Author and review evaluation tasks based on DSURs PSURs/PBRER safety data and case-level records
- 2Assess safety findings signal evaluations and 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 and inconsistencies
- 5Evaluate safety conclusions using new data events and regulatory requirements
- 6Provide structured written feedback rationales supporting AI pharmacovigilance tools
- 7Ensure accuracy completeness and quality of regulatory safety documentation
Requirements10
- 1Pharmacovigilance Drug Safety Report Authoring DSUR/PSUR/PBRER Review
- 2ICH E2F ICH E2C(R2) Compliance GVP Guidelines
- 3Aggregate Safety Data Analysis Signal Management Benefit-Risk Assessment
- 4MedDRA Coding Seriousness & Causality Assessment Expectedness Determination
- 5Data Reconciliation Regulatory Documentation Structured Written Communication
- 6Attention to Detail Preferred Qualifications 5+ years pharmacovigilance drug safety experience
- 7Proven authoring or reviewing DSURs and/or PSURs/PBRERs
- 8Strong knowledge of ICH E2F ICH E2C(R2) signal management MedDRA coding safety data analysis
- 9Experience reconciling aggregate safety data with case-level information
- 10Advanced degree in life sciences pharmacy nursing medicine or related field
Salary Insight
$146 - $166k per year
Location
Required Skills
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