Remote Pharmacovigilance Expert for AI-Driven Safety

YO AI Labs; Illinois; Remote; USD 96,000 - 152,000; Full time

Job summary

YO AI Labs is seeking a experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. This contractor role involves reviewing pharmacovigilance documentation, safety reports, and regulatory content to support AI-driven safety analysis.

The ideal candidate brings 5+ years in pharmacovigilance, familiarity with DSUR/PSUR/PBRER, ICH E2F/E2C(R2), and GVP guidelines, and a rigorous eye for data quality. Remote work available.

Qualifications

• Experience in pharmacovigilance and drug safety.
• Authoring/reviewing DSURs/PSURs/PBRERs.
• Knowledge of ICH E2F, ICH E2C(R2) and GVP.
• Experience with signal management and safety data analysis.
• Strong data reconciliation and regulatory documentation skills.
• Excellent written communication.

Responsibilities

• Author and review DSURs, PSURs, and safety data.
• Evaluate safety findings and regulatory alignment.
• Review reports for ICH and GVP compliance.
• Analyze aggregate safety data and reconcile data sources.
• Provide structured feedback for AI-driven pharmacovigilance tools.
• Ensure accuracy of regulatory safety documentation.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR/PSUR/PBRER Review

ICH E2F & ICH 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, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent)

Job description

YO AI Labs is seeking a experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. This contractor role involves reviewing pharmacovigilance documentation, safety reports, and regulatory content to support AI-driven safety analysis.

The ideal candidate brings 5+ years in pharmacovigilance, familiarity with DSUR/PSUR/PBRER, ICH E2F/E2C(R2), and GVP guidelines, and a rigorous eye for data quality. Remote work available.