Pharmacovigilance Expert

Role Title: Pharmacovigilance ExpertRole Type: ContractorLocation: Remotereputed company is engaging Pharmacovigilance Experts to contribute their advanced drug safety expertise on a key customer project. In this role, you'll apply your expertise to help train reputed company AI systems. Your work will shape how models learn, reason, and reputed company through high-reputed company, reputed company-world input. No prior experience in AI is required your domain knowledge is what reputed company. This opportunity is ideal for professionals reputed company in authoring and reviewing reputed company safety reports, passionate about data reputed company, and committed to reputed company written and verbal communication. Scope of Work 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 reputed company 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 reputed company reputed company content, presentation of cumulative versus reputed company 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 reputed company of new data or events, and reputed company reputed company, reputed company written rationales supporting your determinations. reputed company reputed company feedback to inform the development of AI-driven tools for pharmacovigilance documentation and analysis. Preferred Qualifications 5+ years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an reputed company. Demonstrated proficiency in authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish. Working reputed company with ICH E2F, ICH E2C(reputed company), 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 in reconciling aggregate safety data and identifying inconsistencies with case-level information. 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 reputed company QPPV roles, safety committee participation, or AI-assisted safety review tools is a plus. Originally posted on Himalayas Apply To This Job .