Remote Pharmacovigilance Expert for AI Safety Reviews

YO AI Labs; San Francisco (CA); Remote; USD 120,000 - 180,000; Part time

Job summary

YO AI Labs is seeking a Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. You will review pharmacovigilance documentation, safety reports, and regulatory content to support AI-enabled safety review tools.

The role emphasizes data quality, analytical evaluation of DSURs/PSURs, and compliance with ICH E2F, ICH E2C(R2), and GVP guidelines. Remote contractor arrangement with flexible collaboration across teams.

Qualifications

• Experience reviewing DSURs/PSURs/PBRERs and related safety documents.
• Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
• Ability to analyze aggregate safety data and reconcile discrepancies.
• Excellent written communication for regulatory documentation.

Responsibilities

• Author and review DSURs, PSURs/PBRERs, safety data, and case-level records.
• Assess safety findings and benefit-risk conclusions for regulatory alignment.
• Review reports for ICH E2F/E2C(R2) and GVP compliance.
• Analyze aggregate safety data and reconcile counts across sources.
• Provide structured written feedback to AI-driven safety tools.
• Ensure accuracy and completeness of regulatory safety documentation.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR/PSUR/PBRER Review

ICH E2F & E2C(R2) Compliance

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Seriousness & Causality Assessment

Expectedness Determination

Data Reconciliation

Regulatory Documentation

Structured Written Communication

Attention to Detail

Education

Advanced degree in life sciences (PharmD, MD, MSc, or equivalent)

Job description

YO AI Labs is seeking a Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. You will review pharmacovigilance documentation, safety reports, and regulatory content to support AI-enabled safety review tools.

The role emphasizes data quality, analytical evaluation of DSURs/PSURs, and compliance with ICH E2F, ICH E2C(R2), and GVP guidelines. Remote contractor arrangement with flexible collaboration across teams.