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California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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

We are seeking an experienced Senior Product Safety Scientist to join our dynamic pharmacovigilance team. You will play a key role in managing the safety profile of our products by supporting signal detection, data analysis, risk management, aggregate reporting, and regulatory compliance activities and should have strong critical thinking, medical writing, and communication skills.

The Senior Product Safety Scientist will serve as a recognized leader and subject matter expert 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, and within the Product Safety Science (PSS) Team, supporting the optimal development and execution of operational procedures and standards. Responsible for providing advanced scientific, technical, and analytical expertise and for leading and independently executing safety and benefit-risk management strategy.

Minimum Requirements

+ Education and Experience Requirements:

+ Bachelor’s degree in a health or science discipline, and 8+ years of experience with safety risk management processes and procedures

+ Master’s Degree in a health or science discipline, with 6+ years of experience with safety risk management processes and procedures

+ Doctor of Philosophy (PhD) in a health or science discipline or Doctor of Pharmacy (PharmD) (or international equivalent), with 2+ years of experience with safety risk management processes and procedures

+ Ability to execute safety science strategy and intermediate analytic and scientific skills

+ Ability to analyze safety concepts or concerns of diverse scope across multiples drugs and/or devices

+ High-level understanding of pharmacology and toxicology to interpret data from a safety perspective

+ Intermediate to advanced knowledge of pharmacovigilance processes and regulatory requirements

+ Advanced knowledge of MedDRA coding conventions and dictionaries

+ Ability and willingness to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes

Preferred Qualifications

+ 1+ years of previous experience using Argus or other safety database including signaling tools

+ 1+ years of previous experience with document management systems, e.g. Documentum, Veeva

+ 1+ years of clinical or academic publication experience

Job Location

This position is located onsite at our Durham, NC office. Relocation assistance may be available.

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.

_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._

_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._