The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you’ll contribute Provide clinical and medical expertise supporting pharmacovigilance for assigned United Therapeutics (UT) product(s)/program(s) across lifecycle. Support all safety and pharmacovigilance responsibilities to ensure favorable benefit-risk balance and business operations. Contribute clinically and medically to teams, supporting signal detection, aggregate reports, labeling, risk management, and clinical R&D. Lead and drive medical safety strategy in collaboration with other product/program leads & teams for PASS or PAES and Observational Studies. Additionally responsible for supporting and defending Pharmacovigilance & medical safety position across product lifecycle. Medically and clinically support all drug safety/pharmacovigilance deliverables required to satisfy regulatory obligations and support clinical development strategies with quality deliverable & timeliness. This includes, but is not limited to, ICSR medical review, aggregate reports/line listing, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submission, dRMP/RMP, REMS, safety variation, routine and ad-hoc signal detection, regulatory questions etc. Provide updates to Benefits: Risk (B:R) Assessment and supporting documentation, including review of blinded data from clinical trials Perform medical review/assessment of ICSR for product assignment, including spot checking of medical review performed by CRO medics for consistency and trend/signal identification Review and document safety findings, and analyze data listings, to identify safety trends or signals for assigned product/program Write HHE for quality issues or patient impact assessment Support development of FMEA and MDR determination for drug device combination or standalone device Lead safety discussions in collaboration with other product or program leads with DMC/DSMB Review and provide input to the study protocol, CIBs, ICFs, IB, and COR development documents impacting patient safety for trials or programs Collaborate with study investigator to clarify and gather further understanding of potentially emerging safety issues/trends or potential safety concerns with specific queries or discussions Collaborate with medical monitors to develop safety mitigation measures for enrolled patients Lead and write safety responses to regulatory authority requests Support MARC, ISS, PAP, and EAP program activities across UT and its partners for assigned product(s) Lead, plan, and support observational studies using safety data in alignment with overall UTC goals Remain current on other business deliverables to ensure business and procedural compliance Train and educate CRO and other teams on assigned product(s) and communicate/educate core safety risks for the product of their responsibilities As required, serve as medical expert for other business activities Perform other duties as assigned For this role you will need Minimum Requirements MD 5 years of professional experience with patient safety at the clinical or medicinal product level 5 years of clinical practice experience within the U.S. 2 years of relevant, international pharmaceutical industry experience (i.e., clinical research, drug safety, medical affairs, medical monitoring) MD - Physician - State Licensure Ability to analyze data to draw medical conclusions Excellent oral and written communication skills to support responses to Health Authority requests & HHE Excellent interpersonal and time management skills, to ensure compliance with firm timelines Ability to think outside of the box and present independent, reasoned solutions to identified safety issues & minimizing risk to patients within the program or commercial therapy Demonstrated problem solving skills that enact change and drive continuous improvement Ability to be flexible, adaptable, and open minded in a constantly changing environment Ability to build and manage cross-functional relationships by motivating and inspiring others Self-starter with ability to work under minimal direction Proficient with MS Office suite (Word, Excel, Outlook, PowerPoint) Preferred Qualifications 2 years of industry experience with pharmaceutical activities such as R&D, leading clinical studies, or serving as principal investigator (PI) 1 years of experience working in a matrix team environment, including supporting other team members when required 1 years of experience with medical review and interpretation of ICSRs Ability to influence stakeholders, reach consensus, and meet critical regulatory, safety & business objectives At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / 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.