Remote Pharmacovigilance Expert for AI Safety

YO AI Labs; North Carolina; Remote; USD 90,000 - 130,000; Full time

Job summary

YO AI Labs seeks an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. In this contractor role, you will review safety data, DSURs/PSURs, and regulatory content to ensure accuracy and regulatory alignment.

Remote work options and the opportunity to shape AI-driven safety reviews are offered; candidates should bring strong pharmacovigilance knowledge, MedDRA coding, and a track record in safety documentation.

Qualifications

• Experience authoring or reviewing DSURs and PSURs/PBRERs.
• Strong knowledge of ICH E2F, ICH E2C(R2) and GVP guidelines.
• Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.
• Experience reconciling aggregate safety data with case-level information.

Responsibilities

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case-level records.
• Assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory alignment.
• Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
• Analyze aggregate safety data and reconcile case counts, figures, and inconsistencies across data sources.
• Evaluate safety conclusions based on new data, events, and regulatory requirements.
• Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools.
• Ensure accuracy, completeness, and quality of regulatory safety documentation.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR Review

PSUR Review/PBRER

ICH E2F Compliance

ICH E2C(R2) Compliance

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Seriousness & Causality Assessment

Data Reconciliation

Regulatory Documentation

Structured Written Communication

Attention to Detail

Education

PharmD, MD, MSc or equivalent

Job description

YO AI Labs seeks an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. In this contractor role, you will review safety data, DSURs/PSURs, and regulatory content to ensure accuracy and regulatory alignment.

Remote work options and the opportunity to shape AI-driven safety reviews are offered; candidates should bring strong pharmacovigilance knowledge, MedDRA coding, and a track record in safety documentation.