Product Safety Scientist - EASTERN AND CENTRAL TIME ZONES REMOTE

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:

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.

In 2021, we became 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.

How you’ll contribute
Contribute to safety risk management strategy and enhance analytic capabilities at the 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 skills 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 processed 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 Arts/Sciences (BA/BS) in a health or science discipline plus 5+ years experience with safety risk management processes and procedures OR Master’s degree (MA/MS/MBA) in a health or science discipline with 3+ years experience with safety risk management processes and procedures OR doctorate level clinical degree (e.g. PharmD, PhD, MD/DO or international equivalent) plus 1+ years experience with safety risk management processes and procedures
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 clearing 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 communications 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

Doctor of Pharmacy (PharmD) may include post-doctoral experience or
Doctor of Philosophy (PhD) in pharmacology or toxicology; may include post-doctoral experience or
MD or DO; may include post-doctoral experience
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
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.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities