Remote Pharmacovigilance Expert - AI-Driven Safety Review

YO AI Labs; Washington (District of Columbia); À distance; USD 90 000 - 150 000; Temps partiel

Résumé du poste

YO AI Labs is seeking a Pharmacovigilance Expert to contribute drug safety expertise to an innovative healthcare AI project. You will review pharmacovigilance documentation, safety reports, and regulatory content to improve AI-driven safety tools.

The contractor role emphasizes analytical skills, data quality, and regulatory alignment. Remote work is available for experienced professionals in pharmacovigilance and safety data analysis.

Qualifications

• Pharmacovigilance expertise and regulatory knowledge required.
• Experience with DSUR/PSUR/PBRER review and safety data analysis.
• Familiarity with ICH E2F, ICH E2C(R2) and GVP guidelines.

Responsabilités

• 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.

Connaissances

Pharmacovigilance

Drug Safety Report Authoring

DSUR Review

ICH E2F & ICH E2C(R2)

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Regulatory Documentation

Structured Written Communication

Attention to Detail

Description du poste

YO AI Labs is seeking a Pharmacovigilance Expert to contribute drug safety expertise to an innovative healthcare AI project. You will review pharmacovigilance documentation, safety reports, and regulatory content to improve AI-driven safety tools.

The contractor role emphasizes analytical skills, data quality, and regulatory alignment. Remote work is available for experienced professionals in pharmacovigilance and safety data analysis.