Pharmacovigilance Professional for AI Model Training

Shape and validate the safety content used across clinical data workflows while applying deep expertise in aggregate safety reporting and benefit-risk assessment.

This role supports the generation and validation of safety-layer content for data rooms and evaluates AI-generated pharmacovigilance deliverables against expert-defined standards.

• Generate and validate clinical safety data, including adverse events, serious adverse event records, patient narratives, discontinuations, and protocol deviations.
• Author complete Development Safety Update Reports and Periodic Benefit-Risk Evaluation Reports, including their component sections.
• Develop prompts, reference outputs, and scoring rubrics to measure an AI agent''s ability to produce aggregate safety reports.

• MD, PharmD, PhD, or equivalent qualification.
• At least 5 years of relevant experience, with 10 to 25 years preferred.
• Demonstrated authorship of aggregate safety reports for both pre-commercial DSUR reporting and post-commercial PBRER reporting.

• Must be located in the United States, Canada, or France.
• Ability to actively interpret benefit-risk profiles using cumulative safety data, exposure estimates, and signal-detection outputs.
• Experience conducting complete fatal-case assessments, including evaluation of investigator and sponsor causality determinations.

• Remote, hourly engagement.
• Minimum availability of 20 to 25 hours per week, with 30 or more hours per week preferred.

$140 to $190 per hour.