Remote Pharmacovigilance Expert for AI-Driven Drug Safety

YO AI Labs; Seattle (WA); On-site; USD 83,000 - 138,000; Full time

Job summary

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to an AI healthcare project. You will review, evaluate, and refine pharmacovigilance documentation, safety reports, and regulatory content while ensuring data quality.

In this contractor role, you will analyze safety data, perform signal management, and provide clear, structured feedback to support AI-driven safety review tools. No AI background is required beyond pharmacovigilance proficiency.

Qualifications

• Pharmacovigilance expertise with regulatory documentation experience.
• Ability to author/review DSURs/PSURs and ensure regulatory alignment.
• Strong MedDRA coding, data reconciliation, and safety data analysis skills.

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 across data sources.
• Provide structured written feedback and rationales to support AI-driven pharmacovigilance tools.

Skills

Pharmacovigilance

Drug Safety Report Authoring

DSUR/PSUR/PBRER Review

ICH E2F & 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, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent)

Job description

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to an AI healthcare project. You will review, evaluate, and refine pharmacovigilance documentation, safety reports, and regulatory content while ensuring data quality.

In this contractor role, you will analyze safety data, perform signal management, and provide clear, structured feedback to support AI-driven safety review tools. No AI background is required beyond pharmacovigilance proficiency.