Remote Pharmacovigilance Expert for AI Safety Review

YO AI Labs; Dallas (TX); Teletrabalho; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. This contract role is remote, allowing you to review safety reports, regulatory content, and DSUR/PSUR materials to help refine AI-driven safety tools.

You will evaluate safety data, assess signal management and benefit-risk conclusions, ensure ICH E2F/E2C(R2) and GVP alignment, and provide structured written feedback to support high-quality regulatory documentation.

Qualificações

• Pharmacovigilance expertise and drug safety knowledge required.
• Experience authoring/reviewing DSURs/PSURs/PBRERs preferred.
• Strong knowledge of ICH E2F/E2C(R2) and GVP guidelines essential.

Responsabilidades

• Author/review evaluation tasks based on DSURs, PSURs/PBRERs, safety data, and case records.
• Assess safety findings, signal evaluations, and benefit-risk conclusions for regulatory alignment.
• Review reports for ICH E2F/E2C(R2) and GVP compliance.
• Analyze aggregate safety data and reconcile counts across sources.
• Provide structured written feedback to support AI-driven pharmacovigilance tools.

Conhecimentos

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

Formação académica

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

Descrição da oferta de emprego

YO AI Labs is seeking an experienced Pharmacovigilance Expert to contribute drug safety expertise to a healthcare AI project. This contract role is remote, allowing you to review safety reports, regulatory content, and DSUR/PSUR materials to help refine AI-driven safety tools.

You will evaluate safety data, assess signal management and benefit-risk conclusions, ensure ICH E2F/E2C(R2) and GVP alignment, and provide structured written feedback to support high-quality regulatory documentation.