Medical Safety Expert | $140-$190/hr Remote
Overview
This project pairs medical safety expertise with AI evaluation. You will build and validate the safety layer of clinical data rooms, covering adverse event data, SAE records, patient narratives, discontinuations, and protocol deviations. You will also author complete DSURs and PBRERs and design prompt sets, golden outputs, and grading rubrics that measure how well an AI agent reproduces pharmacovigilance work. The role requires an MD, PharmD, or PhD and prior authorship of both pre- and post-commercial aggregate reports. Work is remote and paid hourly at $140-$190 per hour.
What You'll Do8
- 1Generate adverse event data sets for each data room, including serious adverse event records, patient narratives, discontinuations, and protocol deviations.
- 2Validate that the safety layer of each data room is complete, accurate, and aligned with source documents.
- 3Author complete DSURs and PBRERs, including all component sections and regulatory language.
- 4Design prompt sets that test an AI agent's ability to produce aggregate safety reports.
- 5Create golden outputs that define correct safety report content for the AI agent to match.
- 6Build scoring rubrics that quantify AI output quality against the golden outputs.
- 7Apply benefit-risk interpretation using cumulative safety data, exposure estimates, and signal detection output.
- 8Conduct full fatal-case workups and document investigator versus sponsor causality assessments.
Requirements7
- 1Based in the US, Canada, or France.
- 2At least 5 years of pharmacovigilance or drug safety experience; 10-25 years preferred.
- 3Holds an MD, PharmD, PhD, or equivalent degree.
- 4Can dedicate 20-25 hours per week minimum; 30+ hours preferred.
- 5Has authored both pre-commercial DSURs and post-commercial PBRERs as lead author.
- 6Skilled in benefit-risk interpretation against cumulative safety data, exposure estimates, and signal detection output.
- 7Comfortable with full fatal-case workups and causality assessment between investigator and sponsor.
Who Should Apply
The ideal candidate has deep pharmacovigilance authority, with a track record of writing DSURs and PBRERs from scratch for both pre- and post-market products. They hold an MD, PharmD, or PhD and have spent at least five years in drug safety, often with 10-25 years in the field. This role suits someone who can commit 20-30+ hours weekly and enjoys translating regulatory reporting expertise into evaluation metrics for AI. Candidates with only clinical experience and no aggregate report authorship will find this role a poor fit. Rejection typically comes from lacking the required report authorship credentials, or from under-committing on availability when the project needs a steady 20-25 hours per week.
Salary Insight
Rate is $140-$190 per hour. The upper end of that range corresponds to the 10-25 years of experience and MD, PharmD, or PhD that this project prefers, and the rate sits at the high end of contract pharmacovigilance work.
Location
Required Skills
Application Tip
Mention your availability for 20-25 hours per week and list the exact DSURs and PBRERs you have authored, including therapeutic area and patient exposure scale. That makes your fit clear immediately.
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How your application is processed
1Application received
Your resume and details are logged the moment you apply.
2ATS + eligibility screening
We check your profile against the role’s skills, seniority, and requirements.
3Employer sees qualified profiles only
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