Pharmacovigilance Documentation AI Training Expert

The Work

You will review and author evaluation tasks that help AI systems reason about drug safety documentation. Your work will cover development-stage and post-marketing safety materials, report quality, regulatory structure, data consistency, and the strength of safety conclusions.

You will provide structured feedback for AI tools used in pharmacovigilance documentation and analysis.

• Author and review tasks based on DSURs, PSURs and PBRERs, related safety data, and case-level records.
• Assess interval safety findings, signal evaluations, and benefit-risk conclusions against pharmacovigilance best practices.
• Check report structure, section content, appendices, and the presentation of cumulative versus interval data.
• Review conformity with ICH E2F and ICH E2C requirements.
• Apply judgment to MedDRA coding, seriousness and causality assessment, expectedness, aggregate safety analysis, and data reconciliation.

What It Pays and Takes

This is a part-time contractor role focused on specialist pharmacovigilance documentation. The posting labels the role entry level, while the preferred background calls for substantial drug safety experience.

• Pay: $70 to $80 per hour, paid hourly in USD.
• Time: 20 or more hours per week.
• Language: English.
• Location: Available in the countries listed in the application; worldwide availability is not indicated.
• Experience: Ideally at least five years in pharmacovigilance or drug safety at a sponsor, CRO, or as an independent consultant.
• Preferred background: End-to-end authoring or review of DSURs and/or PSURs/PBRERs, from data pull through final signed report.
• Knowledge: Working fluency with ICH E2F, ICH E2C(R2), and GVP guidance, including signal management and benefit-risk methodology.
• Education: An advanced degree in life sciences, pharmacy, nursing, or medicine, such as a PharmD, MD, MSc, or equivalent, is preferred.
• Helpful experience: Development-stage and post-marketing safety reporting, QPPV or deputy QPPV responsibilities, safety committee participation, or AI-assisted safety review tools.
• Personal skills: Clear writing, careful documentation, and strong attention to detail.

How It Works

Apply on OpenTrain with your resume, then complete the application on the hiring site.

About AI Training Work

AI training is the human work behind systems that learn from examples, including reviewing documents and rating model outputs. Specialists are paid to apply professional judgment so these systems produce more accurate and useful results.