Pharmacovigilance Documentation AI Training Expert

About OpenTrain

OpenTrain is the #1 platform for finding and building careers in AI training and data labeling. OpenTrain AI engages specialists for projects that help shape how modern AI systems learn, reason, and perform in real-world domains.

As an OpenTrain contractor, you can apply your professional expertise to emerging AI systems while building a credible portfolio of specialized training work. Creating an OpenTrain account is free.

About AI Training Work

AI training is the human side of building artificial intelligence. Experts review documents, assess model outputs, create evaluation examples, and provide structured feedback so AI systems can become more accurate and useful.

This work is remote and often flexible, making it possible to contribute to cutting-edge technology while fitting projects around other professional or personal commitments.

The Role

OpenTrain AI is seeking a Pharmacovigilance Documentation AI Training Expert to review and author evaluation tasks for AI systems that reason about drug-safety documentation. You will work with development-stage and post-marketing safety materials, applying advanced pharmacovigilance judgment to report quality, regulatory structure, data consistency, and safety conclusions.

The work covers DSURs, PSURs and PBRERs, aggregate safety data, case-level records, and structured feedback for AI-driven pharmacovigilance documentation and analysis tools. The project is listed as entry level in the source details, while the role description identifies substantial specialist experience as preferred.

• Contractor, part-time engagement
• Worldwide remote opportunity
• 20+ hours per week
• English-language work
• $70–$80 USD per hour

What You’ll Do

You will create and review evaluation tasks based on development-stage and post-marketing safety documentation. Your assessments will help determine whether AI-generated or AI-assisted work reflects sound pharmacovigilance practice and accurately handles both aggregate and case-level information.

• Author and review evaluation tasks using DSURs, PSURs/PBRERs, associated 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, and the presentation of cumulative versus interval data.
• Review appendices for conformity with ICH E2F and ICH E2C requirements.
• Provide clear, structured feedback for AI tools used in pharmacovigilance documentation and analysis.

Requirements and Preferred Experience

The strongest candidates will bring advanced practical experience in pharmacovigilance or drug safety, along with the ability to communicate detailed judgments clearly and document them carefully. An advanced degree in life sciences, pharmacy, nursing, or medicine is preferred.

• At least five years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant is preferred.
• End-to-end authorship or review of DSURs and PSURs/PBRERs, from data pull through final signed report, is preferred.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidance for aggregate safety reporting.
• Practical expertise in signal evaluation, benefit-risk assessment, seriousness, causality, and expectedness determinations.
• Hands-on knowledge of MedDRA coding, aggregate safety analysis, and reconciliation of aggregate data with case-level safety records.
• Clear written communication, careful documentation, and strong attention to detail.

Additional Experience That Helps

The following background can strengthen your application and may help you contribute across a wider range of evaluation tasks.

• Experience with development-stage and post-marketing safety reporting.
• QPPV or deputy QPPV responsibilities.
• Participation in safety committees.
• Experience with AI-assisted safety review or analysis tools.
• Advanced training such as a PharmD, MD, MSc, or equivalent qualification.

Why Work With OpenTrain

OpenTrain helps specialists discover meaningful AI training projects, organize their work history, and build a durable professional portfolio. Your pharmacovigilance expertise can directly improve the quality of AI systems used to interpret safety documentation and analysis.

With flexible remote contract work, you can contribute to the fast-growing AI training industry while demonstrating specialized experience through a portfolio built around the work you complete.