Pharmacovigilance Expert

• Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
• Apply expert judgment to assess the accuracy and adequacy of interval safety findings, signal evaluations, and benefit-risk conclusions in alignment with best practices.
• Assess template and structural conformity to ICH E2F and ICH E2C requirements, including proper section content, presentation of cumulative versus interval data, and completeness of appendices.
• Reconcile figures and case counts across report sections and data sources, identifying and documenting discrepancies significant for regulatory review.
• Evaluate safety conclusions in light of new data or events, and provide clear, structured written rationales supporting your determinations.
• Deliver structured feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis.

• Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
• Working fluency with ICH E2F, ICH E2C(R2), and GVP guidelines, including signal management and benefit-risk assessment methodology.
• Expertise in reconciling aggregate safety data and identifying inconsistencies with case-level information.
• Clear, structured written and verbal communication.

• 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
• Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
• Advanced degree in life sciences, pharmacy, nursing, or medicine (PharmD, MD, MSc, or equivalent).
• Experience in both development-stage and post-marketing safety reporting, QPPV or deputy QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus.

RequiredAlso useful

Also listed: attention to detail.

Project and contracting process: micro1. Applications continue on the provider's website.