California, US residents

The job details are as follows:

Who we are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were 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. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who you are

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. 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

Job Location & Travel

This position is located at our Durham, NC office.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.