Medical Director, Safety Risk Management

United Therapeutics (Nasdaq: UTHR) is hiring a Medical Director, Safety Risk Management to provide pharmacovigilance, regulatory, and medical expertise across product lifecycles. Responsibilities 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 Minimum Requirements MD 5+ years of professional experience with patient safety at the clinical or medicinal product level 5+ years of clinical practice experience 3+ years of relevant, international pharmaceutical industry experience (i.e., clinical research, drug safety, medical affairs, medical monitoring) 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 Preferred Qualifications 5+ years of industry experience with pharmaceutical activities such as R&D, leading clinical studies, or serving as principal investigator (PI) 2+ years of experience working in a matrix team environment, including supporting other team members when required 5+ years of experience with medical review and interpretation of ICSDs MD - Physician - State Licensure Ability to influence stakeholders, reach consensus, and meet critical regulatory, safety & business objectives Job Location This position will be located at our Durham, NC office with a hybrid schedule of 3 days in office and the option to work 2 days each week from home. In office requirements could change based on business needs. This position may travel up to 10%. Relocation assistance may be available for non-local candidates. Benefits 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 Equal Opportunity Employer United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. #J-18808-Ljbffr Dormont Manufacturing Co