Job Title
Pharmacovigilance Expert - AI Trainer
Job Type
Contractor
Compensation Structure
Compensation is hourly. The hourly rate will be determined based on experience, qualifications, and project requirements.
Location
Remote
Job Summary
In this role, you'll apply your pharmacovigilance expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input.
No prior experience in AI is required—your expertise in drug safety and pharmacovigilance is what matters most.
You'll contribute to the development of AI systems by reviewing safety documentation, evaluating pharmacovigilance reports, and applying expert judgment to ensure scientific accuracy and regulatory compliance.
Key Responsibilities
- Author and review evaluation tasks based on DSURs, PSURs/PBRERs, and associated safety data and case-level records.
- Assess interval safety findings, signal evaluations, and benefit-risk conclusions in accordance with pharmacovigilance best practices.
- Evaluate reports for compliance with ICH E2F and ICH E2C requirements, including document structure, cumulative versus interval data, and appendix completeness.
- Reconcile figures and case counts across report sections and source data, identifying and documenting discrepancies.
- Evaluate safety conclusions in light of new data or events and provide structured, evidence-based written rationales.
- Deliver detailed feedback to support the development of AI-powered pharmacovigilance documentation and analysis tools.
Required Skills and Qualifications
- Minimum of 5 years of pharmacovigilance or drug safety experience at a sponsor, CRO, or as an independent consultant.
- Demonstrated experience authoring or reviewing DSURs and/or PSURs/PBRERs from start to finish.
- Strong knowledge of ICH E2F, ICH E2C(R2), GVP guidelines, signal management, and benefit-risk assessment methodologies.
- Hands-on experience with MedDRA coding, seriousness and causality assessment, expectedness determination, and aggregate safety data analysis.
- Experience reconciling aggregate safety data with case-level information.
- Advanced degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related field (PharmD, MD, MSc, or equivalent).
- Excellent written and verbal communication skills with exceptional attention to detail.
Preferred Qualifications
- Experience with both development-stage and post-marketing safety reporting.
- Previous experience serving as a QPPV or Deputy QPPV.
- Participation in drug safety committees or pharmacovigilance governance activities.
- Familiarity with AI-assisted pharmacovigilance or safety review tools.
Job Type: Contract
Pay: $70.00 - $80.00 per hour
Benefits:
Work Location: Remote
