Senior Product Safety Scientist Position Available In [Unknown county], North Carolina

Senior Product Safety Scientist Senior Product Safety Scientist
remote type
On-Site
locations
RTP, NC
time type
Full time
posted on
Posted 7 Days Ago
job requisition id
R04144
California, US residents The job details are as follows:
Who We Are
We are the first publicly-traded biotech or pharmaceuticalpany 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 transplantableans.
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 anan transplant, but only a small percentage of donatedans are available to address the vast need. For this reason, we are working to create manufacturedans to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantableans will eliminate the transplant waiting list and cure end-stagean 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 regulatorypliance activities and should have strong critical thinking, medical writing, andmunication 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, andmit 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’sprehensive 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 unither/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.