Remote Pharmacovigilance Expert for AI Safety Reviews

YO AI Labs; California (MO); Remote; USD 90,000 - 130,000; Part time

Job summary

YO AI Labs seeks a Pharmacovigilance Expert on a remote contractor basis to contribute drug safety expertise to an AI-driven healthcare project. You will review safety reports, DSUR/PSUR/PBRER content, and regulatory documentation to support AI tools.

You will ensure compliance with ICH E2F, ICH E2C(R2) and GVP guidelines, analyze aggregate safety data, and provide structured feedback to improve data quality and regulatory alignment.

Qualifications

• Experience delivering pharmacovigilance support for safety documentation and regulatory content.
• Ability to author/review DSURs and PSURs/PBRERs with regulatory alignment.
• Strong knowledge of ICH E2F, ICH E2C(R2) and GVP guidelines.
• Experience with signal management, MedDRA coding, and data reconciliation.

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 regulatory alignment.
• Review reports for compliance with ICH E2F, ICH E2C(R2), and GVP guidelines.
• Analyze aggregate safety data and reconcile counts across data sources.
• Provide structured written feedback to support AI-driven pharmacovigilance tools.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR/PSUR/PBRER Review

ICH E2F Compliance

ICH E2C(R2) Compliance

GVP Guidelines

Aggregate Safety Data Analysis

MedDRA Coding

Signal Management

Regulatory Documentation

Job description

YO AI Labs seeks a Pharmacovigilance Expert on a remote contractor basis to contribute drug safety expertise to an AI-driven healthcare project. You will review safety reports, DSUR/PSUR/PBRER content, and regulatory documentation to support AI tools.

You will ensure compliance with ICH E2F, ICH E2C(R2) and GVP guidelines, analyze aggregate safety data, and provide structured feedback to improve data quality and regulatory alignment.