Remote Pharmacovigilance Expert for AI Safety Reviews

YO AI Labs; San Jose (CA); Remote; USD 83,000 - 152,000; Part time

Job summary

YO AI Labs is seeking a Pharmacovigilance Expert to contribute pharmacovigilance expertise to a healthcare AI project. This contractor role is remote and focuses on reviewing safety documentation, DSURs, PSURs, and regulatory content to support AI-driven safety tools.

Ideal candidates have 5+ years in PV, strong knowledge of ICH guidelines, MedDRA coding, and data reconciliation. This is a flexible remote engagement with emphasis on accuracy, regulatory alignment, and structured written

Qualifications

• Minimum 5+ years in pharmacovigilance or drug safety within a sponsor, CRO, or consulting environment.
• Experience authoring or reviewing DSURs and/or PSURs/PBRERs.
• Strong knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines.
• Hands-on experience with signal management, benefit-risk assessment, MedDRA coding, and safety data analysis.

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

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Data Reconciliation

Regulatory Documentation

Structured Written Communication

Attention to Detail

Education

Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent)

Job description

YO AI Labs is seeking a Pharmacovigilance Expert to contribute pharmacovigilance expertise to a healthcare AI project. This contractor role is remote and focuses on reviewing safety documentation, DSURs, PSURs, and regulatory content to support AI-driven safety tools.

Ideal candidates have 5+ years in PV, strong knowledge of ICH guidelines, MedDRA coding, and data reconciliation. This is a flexible remote engagement with emphasis on accuracy, regulatory alignment, and structured written