United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.
The job details are as follows:
This role will consider remote candidates in the EST and CST timezones.
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
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, pediatric cancers and other orphan diseases.
How you’ll contribute
The Principal Product Safety Scientist (PSS) will play an integral role in developing a safety risk management strategy with cross-functional impact. This includes serving as a recognized expert and leader within the Product Safety Science team with the ability to establish critical strategic and operational goals for the overall PV team. They will work independently to lead the development of new procedures, standards, techniques, and tools of critical importance in supporting Product Safety Science and pharmacovigilance strategy. The Principal PSS also provides product-specific scientific direction and guidance regarding management of the safety profile for assigned products through collaboration with a matrix team and cross-functional stakeholders. They will be centrally involved in safety-related and benefit-risk decision making activities throughout the lifecycle of their products and in defining long-term safety-related objectives. A Principal PSS is focused on cross-functional impact and influence as it relates to maintaining the benefit-risk of their products, as well as furthering the scope and utility of Product Safety Science.
- Lead, implement, and participate in activities related to pharmacovigilance safety surveillance, aggregate safety analysis, and aggregate report preparation (PADER, PSUR, DSUR, ASR)
- Contribute to the development and implementation of global risk management strategy over the lifecycle of a product
- Contribute and/or lead the management of the product safety profiles and risk minimization strategy by guiding the approach for monitoring, analyzing/evaluating, and communicating/articulating product-specific safety information in collaboration with the Product Safety Risk Management Matrix Team
- Lead the creation and maintenance of Company Core Safety Information and local and core Risk Management Plans
- Contribute and/or lead the development and preparation of the safety section of clinical study protocols, informed consent forms, investigator’s brochures, and integrated safety/efficacy summaries; ensure that any measures outlined to manage patient risks are appropriate, feasible, and reasonable in achieving overall clinical aims
- Contribute to the interpretation of nonclinical, clinical, and post-marketing safety data to identify emerging safety concerns and/or safety signals as a part of signal detection in alignment with clinical and statistical considerations
- Contribute to interpreting the impact of safety data on the overall benefit-risk balance of a product
- Produce high quality, accurate, and fit-for-purpose safety assessment/evaluation documents with clear conclusion 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.)
- Contribute to the development and preparation of safety sections of marketed/local labeling in the context of core safety information and emerging safety concerns of safety signals
- Perform as subject matter expert, serve as a core member of safety governance committees, and liaise with Clinical Development, Clinical Operations, Medical Affairs, Nonclinical Development, Regulatory Affairs, Quality, and contract research organizations to contribute to ensuring safety strategy, implementation of risk management approaches and measurement of effectiveness, and operational excellence
- Ensure compliance with current global PV regulations and guidelines (e.g. CIOMS, EMA, FDA, ICH, etc.) and stay updated on new/emerging PV/safety regulations and guidance
- Develop and update assigned SOPs and processes to ensure a philosophy of continuous improvement
- Assist with the execution of CAPAs addressing compliance gaps/failures resulting from inspection and/or audit findings related to risk management activities
- Mentor junior members of the Product Safety Science team
- Perform other duties and responsibilities as assigned
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) with 10+ years of relevant scientific PV experience or Master’s degree (MA/MS/MBA) with 8+ years of relevant scientific PV experience
- 5+ years of experience with safety strategy related to benefit-risk management
- 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
- Ability to develop and implement safety science strategy and advanced analytic and scientific skills
- Ability to analyze complicated, multidimensional issues requiring broad based consideration of variables and independently develop appropriate strategies to address such issues
- Prior experience as a practicing nurse
- Scientific knowledge of pharmacology and toxicology to interpret data from a safety perspective
- Extensive knowledge of pharmacovigilance processes and regulatory requirements necessary to address complex situations
- Expert knowledge of MedDRA coding conventions and dictionaries
- Strong medical and scientific writing ability with ability to convey medical- and scientific-related concepts and conclusions clearly and effectively
- Project management skills and ability to organize and deliver large, complex documents in accordance with regulatory specifications
- Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
- Strong computer skills with extensive experience working with PV software (Argus and Empirica) and the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Excellent problem solving, strategic decision-making, and analytical skills with strong clinical underpinning
- Strong communication and interpersonal skills
- Demonstrates qualities of competency, accountability, initiative and ability to work effectively in ambiguous situations and under pressure
- Adaptable, self-starter with proven ability to thrive in fast-paced environment handling multiple simultaneous priority tasks
- Doctor of Pharmacy (PharmD) with 5+ years of relevant scientific PV experience; may include post-doctoral experience or Doctor of Philosophy (PhD) in pharmacology or toxicology with 5+ years of relevant scientific PV experience; may include post-doctoral experience or
- MD (or DO) with 5+ years of relevant scientific PV experience; may include post-doctoral experience
- 1+ years of clinical or academic publication experience
- Certified Project Management Professional (PMP)-PMI helpful, but not required
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.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities