Product Safety Scientist - Remote Eligible

Product Safety Scientist

United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH), today we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant.

The Product Safety Scientist will serve as a recognized leader within the Product Safety Risk Management Matrix Team (PSRMMT), collaborating with a Brand Safety Lead (BSL) and cross-functional stakeholders to manage the safety profile for assigned product(s) throughout their lifecycle. This role is responsible for providing scientific and analytical expertise and for leading and executing safety and benefit-risk management strategy.

Minimum Requirements

Education and Experience Requirements:

• Bachelor's degree in a health or science discipline and 5+ years of experience with safety risk management processes and procedures
• Master's degree in a health or science discipline and 3+ years of experience with safety risk management processes and procedures
• PharmD/PhD (or international equivalent) and 1+ years of experience with safety risk management processes and procedures

Clinical knowledge of medical concepts/conditions and associated pathology to identify and analyze potential safety issues

Intermediate understanding of pharmacology and toxicology to interpret data from a safety perspective

Intermediate knowledge of pharmacovigilance processes and regulatory requirements

Intermediate knowledge of MedDRA coding conventions and dictionaries

Preferred Qualifications

Master's Degree in a health or science discipline or Doctor of Philosophy (PhD) in a health or science discipline or Doctor of Pharmacy (PharmD)

1+ years of previous experience using Argus or other safety database including signaling tools or 1+ years of previous experience with document management systems, e.g. Documentum, Veeva or 1+ years of clinical or academic publication experience

This position is located at our Durham, NC office.