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 Contribute to safety risk management strategy and enhance analytic capabilities at the Product Safety Risk Management Matrix Team (PSRMMT) matrix level. Provide product-specific scientific support regarding management of the safety profile for assigned products throughout their lifecycle through collaboration with a matrix team and cross-functional stakeholders. Serve as a recognized leader within the PSRMMT and apply basic theory and implement basic understanding relevant to benefit-risk management core concepts. Adapt existing procedures, standards, analytical techniques, and tools of critical importance in supporting the activities of the PSRMMT. Analyze safety concepts or concerns of defined scope across assigned product(s) under general supervision and collaborate on executing pharmacovigilance strategy. Establish proficiency in implementing safety science strategy and basic analytic and scientific skills. Contribute to the implementation and coordination of activities related to pharmacovigilance safety surveillance, aggregate safety analysis, and aggregate report preparation (PADER, PSUR, DSUR, ASR) Contribute to the implementation of global safety risk management strategy over the lifecycle of a product Contribute to the management of the product safety profiles and risk minimization strategy by supporting the approach for monitoring, analyzing, and evaluating product-specific safety information in collaboration with the Product Safety Risk Management Matrix Team Contribute to the creation and maintenance of Company Core Safety Information and local and core Risk Management Plans. Contribute to the development and preparation of the safety section of clinical study protocols, informed consent forms, and investigator’s brochures Organize and analyze nonclinical, clinical, and post-marketing safety data to present the safety profile of assigned products Contribute to the interpretation and benefit-risk impact of safety data as a part of signal detection in alignment with clinical and statistical considerations Produce high quality, accurate, and fit-for-purpose safety assessment/evaluation documents in response to internal or regulatory authority request for safety signals or safety inquiries (e.g. PRAC response, FDA inquiry, safety topic assessment reports, etc.) with mentorship and support Interpret trends in drug- and device-related product complaint reporting and evaluate the impact on the treated patient population with respect to the drug or device alone and collectively via routine and ad-hoc safety risk management activities Collaborate with Drug Quality and Device Operations teams to put forward risk minimization measures to ensure positive benefit-risk balance Establish strong analytic capability and clinical approach as these skill sets relate to articulating and assessing product-specific safety information and critically describing the safety profile of a product Develop professional independence and a deep understanding of the PV system with a focus on analytical safety science Develop skills necessary to serve as safety and benefit risk management subject matter expert for assigned products and a core member the Product Safety Risk Management Matrix Team Serve as an influential and collaborative team member when interacting with PSRMMT to ensure appropriate implementation of PV processes and procedures which facilitate efficient and effective safety risk management practices and operational excellence Ensure compliance with current global PV regulations and guidelines (e.g. CIOMS, EMA, FDA, ICH, etc.) Develop and update assigned SOPs and processes to ensure a philosophy of continuous improvement Provide guidance for junior team members Perform other duties and responsibilities as assigned For this role you will need Minimum Requirements Bachelor’s degree in a health or science discipline 5 years of experience with safety risk management processes and procedures with a Bachelor's degree or 3 years of experience with safety risk management processes and procedures with a Master's degree or 1 years of experience with safety risk management processes and procedures with a PharmD/PhD or international equivalent Ability to collaborate on the execution of safety science strategy and basic analytic and scientific skills Ability to analyze safety concepts or concerns of defined scope across drugs and/or devices Clinical knowledge of medical concepts/conditions and associated pathology to identify and analyze potential safety issues Intermediate understanding of pharmacology and toxicology to interpret data from a safety perspective Intermediate knowledge of pharmacovigilance processes and regulatory requirements Intermediate knowledge of MedDRA coding conventions and dictionaries Developing medical and scientific writing ability with ability to convey basic medical- and scientific concepts and conclusions clearly and concisely Developing project management skills and ability to deliver straight forward regulatory required documents in accordance with appropriate specifications Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes Strong computer skills with intermediate experience working with PV software (Argus and Empirica) and advanced experience with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) Strong problem solver with intermediate analytical skills supporting sound clinical decision making Strong communication and interpersonal skills Demonstrates qualities of competency and accountability and ability to work effectively in ambiguous situations and under pressure in a fast-paced environment Preferred Qualifications Master’s degree in a health or science discipline or Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) 1 years of previous experience using Argus or other safety database including signaling tools or 1 years of previous experience with document management systems, e.g. Documentum, Veeva or 1 years of clinical or academic publication experience 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.