Medical Safety Expert | Remote

Role Responsibilities

• Generate and validate the safety layer of clinical data rooms, including adverse event data and SAE records.
• Author full DSURs and PBRERs, designing prompts and rubrics for AI agent evaluation.
• Interpret active benefit-risk against cumulative safety data and exposure estimates.
• Conduct full fatal-case workups, including investigator versus sponsor causality.

Requirements

• Have strong relevant experience in authoring aggregate safety reports across DSUR and PBRER reporting.
• Must be comfortable with active benefit-risk interpretation and signal detection output.
• Experience with full fatal-case workups, including investigator versus sponsor causality.
• Education: MD, PharmD, PhD, or equivalent.

Pay

$140-$190 per hour

Schedule

10-40 hrs/week