Remote Pharmacovigilance Expert for AI Safety Reviews

YO AI Labs; Maryland; Remote; USD 83,000 - 165,000; 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 and refine pharmacovigilance documentation, safety reports, and regulatory content, applying ICH and GVP standards.

AI-backed safety reviews will benefit from your expertise and attention to data quality. The role emphasizes analysis of safety data, DSURs/PSURs, and risk assessment to ensure regulatory alignment.

Qualifications

• Experience in pharmacovigilance or drug safety.
• Authoring or reviewing DSURs/PSURs/PBRERs preferred.
• Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
• Experience with signal management and MedDRA coding.
• Data reconciliation across safety datasets.

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 Compliance

ICH E2C(R2) Compliance

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Seriousness & Causality

Data Reconciliation

Regulatory Documentation

Structured Written Communication

Attention to Detail

Job description

YO AI Labs is seeking a Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. You will review and refine pharmacovigilance documentation, safety reports, and regulatory content, applying ICH and GVP standards.

AI-backed safety reviews will benefit from your expertise and attention to data quality. The role emphasizes analysis of safety data, DSURs/PSURs, and risk assessment to ensure regulatory alignment.