Remote Pharmacovigilance Expert for AI-Driven Safety

YO AI Labs; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Part time

Job summary

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. In this contract role, you will review safety documentation, case records, and regulatory content to help improve AI systems without requiring prior AI experience.

Candidates should bring strong pharmacovigilance knowledge, expertise in DSUR/PSUR/PBRER review, ICH E2F, E2C(R2), and GVP guidelines, plus data quality focus and structured communication.

Qualifications

• Pharmacovigilance knowledge is essential.
• Ability to author and review safety reports and DSURs/PSURs/PBRERs.
• Strong familiarity with ICH E2F, ICH E2C(R2) and GVP guidelines.
• Proficiency in aggregating and reconciling safety data.
• Experience with MedDRA coding and safety data analysis.

Responsibilities

• Author and review evaluation tasks based on safety data, DSURs/PSURs/PBRERs, and case 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 case counts across data sources.
• Evaluate safety conclusions with new data and regulatory requirements.
• Provide structured written 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 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

Advanced degree in life sciences or related field (PharmD, MD, MSc)

Job description

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. In this contract role, you will review safety documentation, case records, and regulatory content to help improve AI systems without requiring prior AI experience.

Candidates should bring strong pharmacovigilance knowledge, expertise in DSUR/PSUR/PBRER review, ICH E2F, E2C(R2), and GVP guidelines, plus data quality focus and structured communication.