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 looking for a highly skilled Senior Pharmacovigilance Specialist with demonstrated experience in end-to-end case processing. In this role, you will be responsible for aiding the successful execution of developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.), and post-approval programs by serving as the subject matter expert (SME), ensuring robust safety data collection for UTC products for proper management of benefit risk and overseeing case processing vendor(s). Collectively, the group of PV specialists are accountable for the conduct of the development programs from the product safety side and end-to-end case management activities of adverse events (AEs), product complaints (PCs). and/or special reporting situations (SRSs) for our development/non-development programs. The Senior PV Specialist will develop, facilitate, and/or provide training and training materials for AE, PC, and/or SRS collection and reporting for developmental, non-development programs (e.g., Phase 1-4 studies, PASS, etc.) & post approval programs in accordance with SOPs, global regulations guidelines and conventions, as well as have oversight and management of vendors to ensure fulfillment of end-to-end case processing requirements in accordance with our company’s processes and global regulatory requirements. **Minimum Requirements** + Education and Experience Required: + Bachelor’s degree in a related field (chemistry or biology) or BSN and 5+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports) + Master’s degree in a related field (chemistry or biology) and 3+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports) + PharmD, PhD, MD/DO, or international equivalent and 0+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs (clinical trial cases & post-marketing reports) + Prior clinical or post marketing experience + Previous experience using Argus (preferred) or other safety databases + Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors + End-to-end case processing (including data entry, QC, medical review, regulatory submissions) + Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of Drug Development & registration of medicines, ensuring their safety + Working knowledge of MedDRA coding + Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products **Preferred Qualifications** + Master’s degree in a related field (chemistry or biology) or + Doctor of Pharmacy (PharmD) PhD, MD/DO or international equivalent + 3+ years of experience in vendor management and oversight and + 3+ years of clinical trial or product development experience **Job Location** 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. _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._