Remote Pharmacovigilance Expert - AI-Driven Safety Reviews

YO AI Labs; Chicago (IL); On-site; USD 83,000 - 152,000; Part time

Job summary

YO AI Labs is seeking an experienced Pharmacovigilance Expert for a remote contractor role focused on drug safety and regulatory documentation. You will review, refine, and author safety reports, DSURs/PSURs, and AI-assisted safety content, ensuring data quality and regulatory alignment across multiple sources.

The ideal candidate has extensive PV expertise, strong analytical skills, and the ability to contribute to AI-driven safety tools while upholding ICH and GVP standards.

Qualifications

• Pharmacovigilance experience in drug safety required.
• Experience authoring/reviewing DSURs/PSURs/PBRERs.
• Knowledge of ICH E2F, E2C(R2) and GVP guidelines.
• MedDRA coding and safety data analysis.
• Strong data reconciliation and regulatory documentation skills.

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/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, PharmD / MD / MSc

Job description

YO AI Labs is seeking an experienced Pharmacovigilance Expert for a remote contractor role focused on drug safety and regulatory documentation. You will review, refine, and author safety reports, DSURs/PSURs, and AI-assisted safety content, ensuring data quality and regulatory alignment across multiple sources.

The ideal candidate has extensive PV expertise, strong analytical skills, and the ability to contribute to AI-driven safety tools while upholding ICH and GVP standards.