Remote Pharmacovigilance Expert for AI Safety Review

YO AI Labs

Philadelphia (Philadelphia County)

Remote

USD 83,000 - 165,000

Part time

14 days+

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Job summary

YO AI Labs seeks an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. You will review, evaluate, and refine pharmacovigilance docs, safety reports, and regulatory content, leveraging analytical skills and data quality focus.

No AI background required, just strong PV acumen. The role emphasizes DSUR/PSUR/PBRER review, regulatory alignment, and structured feedback to AI-driven safety tools, ensuring comprehensive regulatory documentation and

Qualifications

Pharmacovigilance expertise with regulatory documentation focus.
Experience reviewing DSURs/PSURs/PBRERs and safety reports.
Familiarity with ICH E2F/E2C(R2) and GVP guidelines.
Ability to analyze safety data and reconcile cases across sources.

Responsibilities

Author and review evaluation tasks based on DSURs, PSURs/PBRERs and safety data.
Assess safety findings and align conclusions with regulatory requirements.
Review reports for ICH E2F/E2C(R2) and GVP compliance.
Analyze aggregate safety data and reconcile counts and inconsistencies.
Provide structured written feedback to AI-driven pharmacovigilance tools.
Ensure accuracy and completeness of regulatory safety documentation.