Medical Safety Expert

Official role description

As a Medical Safety Expert on this project, you would own a part in multiple workflows: — 1. Clinical Data Generation: we need to generate and validate the safety layer of each data room, including adverse event data, SAE records, patient narratives, discontinuations, and protocol deviations. — 2. PV task authorship: you must be capable of authoring full DSURs and PBRERs and their component sections, and designing prompts, golden outputs, and rubrics to quantify the ability of an AI agent attempting to do the same thing. — To be qualified for this role, you must fit the following requirements: • Location: US, Canada, or France. • YOE: 5+ required. 10-25 preferred. • Education: MD, PharmD, PhD, or equivalent. • Hourly availability: 20-25 hours/week, minimum. 30+ preferred. • Experience: MUST have authored aggregate safety reports across both pre-commercial (DSUR) and post-commercial (PBRER) reporting. Comfortable with active benefit-risk interpretation against cumulative safety data, exposure estimates, and signal detection output, and with full fatal-case workups including investigator versus sponsor causality.