Medical Safety Expert for AI Training

Role Overview

Support the generation, validation, and interpretation of clinical safety data while helping assess AI-authored pharmacovigilance deliverables.

Key Responsibilities

• Generate and validate safety content for clinical data rooms, 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.
• Design prompts, reference outputs, and evaluation rubrics to measure an AI agent''s ability to produce pharmacovigilance reports.
• Interpret benefit risk in the context of cumulative safety data, exposure estimates, and signal detection outputs.
• Complete fatal case evaluations, including assessment of investigator and sponsor causality.

Qualifications

• 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 precommercial DSUR reporting and postcommercial PBRER reporting.

Work Terms

• Remote, hourly engagement.
• Applicants must be located in the United States, Canada, or France.
• Availability of at least 20 to 25 hours per week is required, with 30 or more hours per week preferred.

Compensation

$140 to $190 per hour.