Pharmacovigilance & Medical Safety Expert

Employer description and requirements

Join a leading AI lab's cutting-edge GenAI team to be at the core of the AI revolution, where your expertise fuels the development of the most advanced Large Language Models.

1. Overview

Join a leading AI lab's cutting-edge GenAI team and help build foundational AI models from the ground up. We're seeking talented Pharmacovigilance and Medical Safety subject-matter experts (SMEs) from the pharmaceutical and biotech industry to bring deep drug safety expertise and elevate the quality of our AI training data. This is a full-time commitment of 40 hours per week.

This is a W-2 employment position with Cincinnatus LLC, with the opportunity to be placed at a leading AI Lab as part of their extended workforce.

2. Key Responsibilities

• Guide research and engineering teams to close knowledge gaps and improve AI model performance in pharmacovigilance, signal detection, benefit-risk assessment, and global safety reporting.
• Design challenging, realistic drug safety tasks, such as case causality assessments, signal evaluation scenarios, aggregate report questions and risk management problems, and write accurate, well-structured solutions.
• Evaluate AI model outputs on drug safety questions for accuracy against ICH E2 guidelines and FDA and EU GVP requirements, and provide clear, written feedback.
• Develop guidelines and detailed rubrics to assess causality reasoning, MedDRA coding judgment, and benefit-risk conclusions across tasks.
• Collaborate with other subject matter experts to ensure consistency and accuracy in training data.

3. Core Qualifications

• 7+ years of dedicated professional experience in Pharmacovigilance or Drug Safety within the pharmaceutical or biotech industry at a recognized, top-tier organization (e.g., a top-25 pharmaceutical company such as Pfizer, Merck, Roche, Novartis, AstraZeneca, Johnson & Johnson, AbbVie, Eli Lilly, Bristol Myers Squibb, Sanofi or GSK; a major biotech such as Amgen, Gilead, Genentech, Regeneron, Vertex or Biogen; a leading CRO such as IQVIA, ICON, Parexel, Syneos Health, PPD/Thermo Fisher, Labcorp/Fortrea or Medpace; or a regulator such as the FDA or EMA).
• Hands-on experience with signal detection and management, and authoring or leading aggregate safety reports (PSUR/PBRER, DSUR, PADER) and risk management plans.
• Working knowledge of a safety database (e.g., Argus, ARISg or Veeva Vault Safety), MedDRA, and ICH E2 and EU GVP requirements.
• Current or most recent role at Senior Manager or Associate Director level or above, with demonstrable career progression (e.g., Drug Safety Scientist → Senior Safety Scientist → Associate Director, Pharmacovigilance → Director, or Safety Physician → Medical Director → Senior Medical Director).
• Ability to engage reliably for at least 40 hours/week during weekdays.
• Experience with AI training or evaluation work, or hands-on use of AI tools in drug safety work, is a plus.
• Strong written communication skills and the ability to explain complex safety and benefit-risk judgments clearly.

About Cincinnatus LLC

Cincinnatus LLC is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for contingent and contract-based opportunities. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives.

Equal Employment Opportunity

Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic.