Job Description

Role Overview

Apply advanced drug safety expertise to help improve AI systems through accurate, high-quality evaluations of pharmacovigilance documentation and safety data. This remote contract role focuses on complex aggregate safety reporting, including DSURs, PSURs, and PBRERs. 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 against established pharmacovigilance practices.
• 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 material to regulatory review.
• Assess safety conclusions in light of new data or events and provide clear, structured written rationales.
• Deliver structured feedback supporting 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 in ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methods.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
• Experience reconciling aggregate safety data and identifying inconsistencies against case-level information.
• 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.

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