Pharmacovigilance Expert for AI Training [Remote]

Apply senior pharmacovigilance and drug safety expertise to author and review complex safety reports and to provide high-quality, structured input that trains next-generation AI systems. This remote contractor role focuses on evaluating DSURs, PSURs/PBRERs, and related safety data and case records for a key customer project, producing clear regulatory-focused rationales and actionable feedback.

• Author and review evaluation tasks based on Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs).
• Assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions using expert judgment and best practices.
• Verify template and structural conformity to ICH E2F and ICH E2C(R2) requirements, including correct section content and the distinction between cumulative and interval data.
• Reconcile figures, tables, and case counts across report sections and data sources, identifying and documenting discrepancies relevant for regulatory review.
• Evaluate safety conclusions in the context of new data or events and prepare clear, structured written rationales supporting determinations.
• Provide structured feedback to inform development of AI-driven pharmacovigilance documentation and analysis tools.

• Pharmacovigilance and drug safety report authoring and review.
• DSUR, PSUR, and PBRER content knowledge and assessment.
• Familiarity with ICH E2F and ICH E2C(R2) compliance and GVP guidelines.
• Aggregate safety data analysis, signal management, and benefit-risk assessment methodology.
• MedDRA coding, seriousness and causality assessment, and expectedness determination.
• Data reconciliation between aggregate and case-level information.
• Regulatory documentation skills and structured written communication with strong attention to detail.

• Preferred 5 or more years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
• Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs end to end.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
• Proven ability to reconcile aggregate safety data with case-level records and to identify inconsistencies.
• 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 is desirable. Roles such as QPPV or deputy QPPV, participation in safety committees, or experience with AI-assisted safety review tools are a plus.

• Engagement type: Independent contractor.
• Location: Fully remote.
• Assignment: Work on a key customer project contributing domain expertise to train and improve AI systems for pharmacovigilance.
• No prior experience with AI is required; domain knowledge is the primary qualification.

• Hourly rate: 70.00 to 80.00 USD per hour.

• Open to independent contractors who meet the listed experience and qualification requirements. Preferred candidates will have 5 or more years of relevant pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.

If you are interested, submit an application. Candidates will be evaluated and vetted for subject-matter expertise through the hiring process, and selected experts will be invited to participate in project tasks and provide structured feedback used to improve AI-driven pharmacovigilance tools.