Remote Pharmacovigilance Expert for AI Safety Review

YO AI Labs; Boston (MA); Remote; USD 90,000 - 130,000; Part time

Job summary

YO AI Labs is seeking an experienced Pharmacovigilance Expert contractor to contribute safety expertise to a healthcare AI project. You will review, evaluate, and refine pharmacovigilance documentation, safety reports, and regulatory content, leveraging data quality and analytical skills.

No prior AI experience is required; pharmacovigilance background matters most. Responsibilities include authoring and reviewing DSURs/PSURs/PBRERs, assessing safety data, and ensuring adherence to ICH

Qualifications

• Pharmacovigilance expertise required.
• Experience with DSURs/PSURs/PBRERs preferred.
• Strong knowledge of ICH E2F, E2C(R2) and GVP guidelines.

Responsibilities

• Author/review evaluation tasks based on DSURs, PSURs/PBRERs, safety data and case records.
• Assess safety findings and ensure regulatory alignment.
• Review reports for ICH/E2 guideline compliance.
• Analyze aggregate safety data and reconcile counts across sources.
• Provide feedback to support AI-driven pharmacovigilance tools.
• Ensure accuracy and quality of regulatory safety documentation.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR/PSUR/PBRER Review

ICH E2F/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

Job description

YO AI Labs is seeking an experienced Pharmacovigilance Expert contractor to contribute safety expertise to a healthcare AI project. You will review, evaluate, and refine pharmacovigilance documentation, safety reports, and regulatory content, leveraging data quality and analytical skills.

No prior AI experience is required; pharmacovigilance background matters most. Responsibilities include authoring and reviewing DSURs/PSURs/PBRERs, assessing safety data, and ensuring adherence to ICH