Pharmacovigilance Professional for AI Training

Role Overview

Apply advanced drug safety expertise to help improve next-generation AI systems through high-quality evaluations, safety-report analysis, and structured feedback. This remote contractor opportunity is designed for professionals with experience authoring and reviewing complex pharmacovigilance reports. Prior AI experience is not required.

Key Responsibilities

• Author and review evaluation tasks using DSURs, PSURs/PBRERs, related safety data, and case-level records.
• Assess interval safety findings, signal evaluations, and benefit-risk conclusions for accuracy and adequacy.
• Evaluate report templates and structure for compliance with ICH E2F and ICH E2C(R2), including section content, cumulative versus interval data presentation, and appendix completeness.
• Reconcile figures and case counts across report sections and data sources, documenting discrepancies that could affect regulatory review.
• Evaluate safety conclusions in light of new data or events and provide clear, structured written rationales.
• Provide structured feedback to support AI-driven pharmacovigilance documentation and analysis tools.

Qualifications

• At least 5 years of pharmacovigilance or drug safety experience with a sponsor, CRO, or as an independent consultant.
• Demonstrated end-to-end experience authoring or reviewing DSURs and/or PSURs/PBRERs.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
• Expertise reconciling aggregate safety data and identifying inconsistencies with case-level information.
• Strong regulatory documentation, structured written communication, and attention to detail.
• An advanced degree in life sciences, pharmacy, nursing, or medicine, such as PharmD, MD, MSc, or equivalent.
• Experience in development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is preferred.

Work Terms

• Remote independent contractor engagement.

Compensation

• $70 to $80 per hour.