Remote Pharmacovigilance Expert for AI-Driven Drug Safety

YO AI Labs; Miami (NM); On-site; USD 55,000 - 85,000; Part time

Job summary

YO AI Labs is seeking an experienced Pharmacovigilance Expert for a remote contractor role. You will review regulatory safety documentation and contribute to AI-driven pharmacovigilance efforts, applying your drug safety expertise to improve data quality and regulatory compliance.

Responsibilities include evaluating DSURs/PSURs, performing signal management, MedDRA coding, and safety data analyses, and providing structured feedback to AI tools while ensuring ICH/GVP alignment.

Qualifications

• Pharmacovigilance expertise and data quality focus.
• Experience reviewing safety reports and DSURs/PSURs/PBRERs.
• Knowledge of ICH E2F, ICH E2C(R2) and GVP guidelines.

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 & ICH E2C(R2) Compliance

GVP Guidelines

Aggregate Safety Data Analysis

Signal Management

Benefit-Risk Assessment

MedDRA Coding

Seriousness & Causality Assessment

Expectedness Determination

Data Reconciliation

Regulatory Documentation

Structured Written Communication

Attention to Detail

Education

Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields

Job description

YO AI Labs is seeking an experienced Pharmacovigilance Expert for a remote contractor role. You will review regulatory safety documentation and contribute to AI-driven pharmacovigilance efforts, applying your drug safety expertise to improve data quality and regulatory compliance.

Responsibilities include evaluating DSURs/PSURs, performing signal management, MedDRA coding, and safety data analyses, and providing structured feedback to AI tools while ensuring ICH/GVP alignment.