Pharmacovigilance Expert Remote
Overview
We seek Pharmacovigilance Expert to enhance AI systems by reviewing drug safety documentation. You will improve next generation AI models through evaluation of pharmacovigilance records. This is a remote contractor position focused on data quality and regulatory compliance.
What You'll Do7
- 1Author and review evaluation tasks using DSURs PSURs PBRERs 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 for AI driven tools
- 7Ensure accuracy completeness quality of regulatory safety documentation
Requirements5
- 15+ years pharmacovigilance experience within sponsor CRO consulting environment
- 2Proven experience authoring or reviewing DSURs PSURs PBRERs
- 3Strong knowledge of ICH E2F ICH E2C R2 and GVP guidelines
- 4Hands-on experience with signal management benefit risk assessment MedDRA coding
- 5Advanced degree in life sciences pharmacy nursing medicine PharmD MD MSc equivalent
Salary Insight
$146 - $166k per year
Location
Required Skills
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