Pharmacovigilance Expert for AI Training [Remote]

Apply your advanced drug safety expertise to author and review complex safety reports and to provide structured, expert feedback that will help train next-generation AI systems for pharmacovigilance. This contractor role is fully remote and focuses on high-quality evaluation of DSURs, PSURs/PBRERs, aggregate safety data, and case-level information. No prior experience in AI is required, your domain knowledge is the priority.

• Author and review evaluation tasks derived from Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and PBRERs, including associated aggregate and case-level data.
• Apply expert judgment to assess interval safety findings, signal evaluations, and benefit-risk conclusions, ensuring alignment with pharmacovigilance best practices.
• Verify template and structural conformity with ICH E2F and ICH E2C(R2) requirements, including correct section content, presentation of cumulative versus interval data, and completeness of appendices.
• Reconcile figures and case counts across report sections and across data sources, identify discrepancies that are significant for regulatory review, and document those discrepancies.
• Evaluate whether safety conclusions remain appropriate in light of new data or events, and provide clear, structured written rationales for determinations.
• Deliver actionable, structured feedback to inform the development and refinement of AI-driven pharmacovigilance documentation and analysis tools.

• Required skills and domain knowledge: pharmacovigilance, drug safety report authoring, DSUR and PSUR/PBRER review, ICH E2F and ICH E2C(R2) compliance, and Good Pharmacovigilance Practices guidelines.
• Technical competencies: aggregate safety data analysis, signal management, benefit-risk assessment methodology, MedDRA coding, seriousness and causality assessment, expectedness determination, and data reconciliation between aggregate and case-level information.
• Strong written communication skills, attention to detail, and experience producing regulatory-quality documentation.
• Preferred: 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant, with demonstrated end-to-end experience authoring or reviewing DSURs and/or PSURs/PBRERs.
• Preferred: advanced degree in life sciences, pharmacy, nursing, or medicine (for example PharmD, MD, MSc, or equivalent).
• Desirable experience: development-stage and post-marketing safety reporting, QPPV or deputy QPPV responsibilities, participation in safety committees, or familiarity with AI-assisted safety review tools.

Engagement type: independent contractor. Location: remote. This role supports a customer project focused on generating high-quality pharmacovigilance training data and evaluations for AI systems. Tasks will center on authoring and reviewing pharmacovigilance evaluation assignments as described above.

Pay rate: 70 - 80 hourly.

• Preferred candidates have 5+ years of relevant pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
• Candidates must be able to engage as independent contractors under the terms of this remote role.

If you are interested, submit your application through the platform used for this opportunity. Candidates will be reviewed and vetted by the platform''s recruiter process to confirm relevant expertise. Approved experts will be matched to the customer project and given detailed evaluation tasks to complete.