United Therapeutics Pharmacovigilance Specialist in Durham, North Carolina
The Job Details are as follows:
What we do
United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
We currently have five approved products on the market and a long-term mission of providing and 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
This role is pivotal to GDS & Pharmacovigilance at UT to ensure compliance of adverse event and serious adverse event (AE/SAE) case management for developmental and non-development programs (e.g., Phase 1-4 studies, PASS, etc.) as well as post approval programs. Collectively, the group of PV specialists ensure that pharmacovigilance end-to-end case management activities are executed in accordance with GvP requirements and all UT processes and procedures to ensure proper management of benefit risk.
Assist in all case management activities by demonstrating sound knowledge of good pharmacovigilance practices and guidelines for clinical trials, post-marketing surveillance and medical devices.
Maintain up-to-date knowledge of required UT products/devices under safety surveillance and regulatory requirements for case processing.
Serve as point of contact with CRO & other functions supporting development/non-development programs for AE/SAE collection & reporting process, queries and safety issues.
Maintain a deep understanding of global regulations, guidelines and industry best practices surrounding end-to-end case management
Ensure compliance with global regulations and guidelines regarding safety data collection, management, reporting and timely processing of individual case reports to ensure GvP compliance.
Research and assess the impact of new PV regulations/GVP information on department processes; develop and execute plan(s) to ensure compliance with updated requirements
Perform and document routine quality assurance checks of clinical trial and post-marketing cases.
Develop/provide trainings to team members and/or vendors on new or updated processes as needed.
Attend and actively participate in relevant project and departmental meetings.
In collaboration with Head of Global Case Management, lead meetings relevant to the scope of work covered by this role; document meeting minutes and inform GDS of key details from external meetings.
Review and coordinate MedDRA and WHO drug coding updates and associated process documents.
Escalate quality and or compliance issues to Head of Global Case MGMT or designee as appropriate.
Collaborate with team members on the development and implementation of new or revised SOPs; updates and maintains procedural documents to reflect current practice related to PV systems.
Review and approve deviations/CAPAs for any ICSR related activity as necessary.
Assist with maintenance of the safety database, including gathering requirements, user-acceptance testing & scenario development to aid in system configuration.
Engage with other GDS & PV team members and explore process efficiency initiatives.
Perform other duties as assigned.
For this role you will need
Bachelor’s degree in a related field, such biology (BSN or PharmD degree preferred)
Minimum of 3 years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs (clinical trial cases & post-marketing reports)
Experience with a global safety database (user testing, business scenario development, etc.)
Clinical trial or product development experience preferred
Previous experience using Argus (preferred) or other safety databases
Strong written and verbal communication skills
Ability to develop long and short-range plans to accomplish business goals and monitor performance against plans and objectives
Working knowledge of drug development processes and activities
Working knowledge of medical concepts, terms, conditions, and associated pathology
Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
Working knowledge of applicable global regulatory requirements
Intermediate ability to use basic system applications, such as Microsoft office products
Intermediate knowledge of research methods and related analyses
Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
Works effectively with colleagues in a matrix organization to facilitate achievement of common goals
Ability to work effectively in ambiguous situations
Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Ability to lead small to medium projects
Good working knowledge of medical/drug coding process (MedDRA and WHO drug dictionary)
Proficiency in processing of safety information of clinical trial, post marketing surveillance and medical devices
Ability to travel as needed, approximately 10%
Life as a Unitherian
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.
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 of job performance and provide state of the art facilities to flourish. This is what makes united Therapeutics a stimulating place to work.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has 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 employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. 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.