Sr Product Safety Scientist/Principal Product Safety Scientist

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

Principal Product Safety Scientist Level:
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

Principal Level Minimum Requirements:

• 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

Principal Level Preferred Qualifications:

• 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

How you’ll contribute

Senior Product Safety Scientist Level:
Contribute to safety risk management strategy and enhance analytic capabilities at the PV department level. Serve as a recognized leader within the Product Safety Science team with the ability to apply theory and implement in-depth understanding relevant to benefit-risk management core concepts. Contribute to the development and implementation of new procedures, standards, analytical techniques, and tools of critical importance in supporting Product Safety Science and pharmacovigilance strategy. 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. Independently analyze safety concepts or concerns of diverse scope across multiple products and determine and execute solutions.

• 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 development and 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 limited oversight or 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 along 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 communication skill while strengthening analytic capability and clinical approach as these skills sets relate to articulating and assessing product-specific safety information
• Perform as safety and benefit risk management subject matter expert for assigned products and serve as a core member the Product Safety Risk Management Matrix Team and Product Safety Management Team
• Serve as an influential and collaborative team member when interacting with other PV functional work streams 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
• Establish ownership of assigned Product Safety Science processes and provide guidance for team members
• Perform other duties and responsibilities as assigned

For this role you will need

Senior Level Minimum Requirements:

• Master’s degree (MA/MS/MBA) in nursing or
• Bachelor’s Degree in Arts/Sciences (BA/BS) in nursing
• 3+ years as a healthcare professional with doctorate level clinical degree (e.g. PharmD, PhD, MD/DO or international equivalent)
• 8+ years as a healthcare professional with a clinical degree (e.g. MSN, BSN)
• 5+ years experience with safety risk management processes and procedures
• Ability to execute safety science strategy and intermediate analytic and scientific skills
• Ability to analyze safety concepts or concerns of diverse scope across multiples drugs and/or devices
• Clinical knowledge of medical concepts/conditions and associated pathology to identify and analyze potential safety issues
• High-level understanding of pharmacology and toxicology to interpret data from a safety perspective
• Advanced to intermediate knowledge of pharmacovigilance processes and regulatory requirements
• Advanced knowledge of MedDRA coding conventions and dictionaries
• Intermediate 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

Senior Level 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.

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