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Form of work
SalaryThe 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
Work in collaboration with Global Product Safety & Pharmacovigilance (GPS & PV) teams to establish and maintain processes and oversight activities to ensure proper Quality Control, training and compliance of GPS & PV day to day business operations. Support education initiatives and training curriculum for all GPS & PV staff, vendors, contractors & other UT employees supporting PV activities. Work with leadership to build strategy and manage the day-to-day operational activities, assisting with strategic decisions applicable for Quality Control, training and compliance (QTC) related activities. Assist with the strategic and tactical process design to promote sustainability and ensure long term success of GPS & PV mission and goals.
- Quality Control: * Initiate and implement strategic Quality Control initiatives impacting all aspects of GPS & PV business operations and regulatory standards
- Training: * Assist with the design, development, and strategic planning of GPS & PV training programs (training plans) for products, processes and international regulations applicable. This includes but is not limited to identifying training needs at the individual or group level in collaboration with other GPS & PV functional leaders. * Lead, assist, and oversee the implementation and maintenance of the GPS/PV Training curricula and facilitate modifications in collaboration with GPS &PV functional leads * Assist with company-wide adverse event and serious adverse event (AE/SAE) training for commercial and clinical programs, including study documents applicable for PV activities * Partner with the Training and Development function at to identify training compliance; manage escalation of non-compliance for GPS & PV team and vendors
- Compliance: * Assist with the development, tracking and measurement of compliance, Quality Control and performance metrics for GPS & PV operational level activities; present metrics to GPS & PV functional team leaders, Head of GPS & PV & QPPV periodically * Assist with escalations, make and implement recommendations to ensure high compliance, Quality Control with ICSRs, Aggregate reports, Signal detection, Trending activities, PVAs, and other key metrics (AKA Key Performance Indicators) * Assist with all pre and post audit and inspection activities, including oversight and management of CAPAs, and process and response management activities (ensuring proper closure of the CAPAs and effectiveness). * Assist with Quality Control, compliance and training SME responsibilities during audits and inspections * Act as a lead and owner for Quality Events for the GPS & PV team. Assist with RCAs and CAPAs development, respectively for all GPS & PV findings or observations or other near misses. * Assist with development and implementation of an effective system to support the lifecycle of inspections and audits (both pre- and post-audit phases) and collaborate closely with GxP Compliance and Quality Assurance (QA) teams to ensure positive regulatory inspection and audit outcomes * Oversee the management, development, and harmonization of GPS & PV policies, procedures, and governing documents including but not limited to SOPs, SOIs, guidance documents, associated forms and templates * Work with GPS & PV functional leadership to initiate the need of new and/or revised SOPs, SOIs and guidance documents, ensuring adequate input from business functions * Drive harmonization of GPS & PV procedural documents to ensure clarity of content, consistency in application, and compliance with applicable policies and regulations
- Affiliate, Alliance & Contract: * Support to the Affiliate, Alliance & Contract (AA&C) team on Vendor Oversight Plans (VOP), the PSMF, QPPV Activities, PVAs, and AA&CM platform support
- Perform all other duties as assigned
For this role you will need
Minimum Requirements
- Bachelor’s Degree in life sciences with advanced training in PV Related tasks
- 10+ years of experience in healthcare or life sciences industry with a Bachelor's degree or
- 8+ years of experience in healthcare or life sciences industry with a Master's degree or
- 5+ years of experience in healthcare or life sciences industry with a PhD, PharmD, MD, or equivalent
- 8+ years of relevant pharmacovigilance and product safety operations experience, including relevant Quality Control, compliance, and training
- 5+ years of ICSR management & inspection/audit experience
- 5+ years of working knowledge of global PV regulation, Quality Control principles
- Working knowledge of PV regulation and quality framework
- Working knowledge of applicable global pharmacovigilance and regulatory requirements across ICSR, aggregate reports, systems, PVAs, etc.
- Advanced and proactive communication skills; convey policy, procedural principles and details to multiple audiences using the most appropriate communication mechanisms
- Strong accountability and executable skills, ability to drive results (CAPAs), collaborate and communicate with GPS/PV functional leaders/vendors and execute on their training needs
- Ability to use advanced features of PV/LMS system applications and to identify ways to address new needs
- Working knowledge of available information sources and ability to navigate multiple channels to secure required information
- Excellent communication skills (written, verbal, etc.)
- Work effectively with colleagues and facilitate achievement of common goals
- Able to adjust to changing business requirements
- Problem solve and actively provide solutions to issues, suggest alternative approaches to improve work practices, and commit to defined changes
- Apply working knowledge of pharmacovigilance processes and requirements to complex situations arising from inspections/audits
- Continually review internal and vendor processes and identify opportunities for improvement based on quality trends; help generate creative solutions to business challenges and foster innovation
- Deep understanding of all GPS & PV working practices (Policies, SOPs, WI, PVA, etc.)
- Basic analytical thinking; able to diagnose complex situations with broad impact and exercise sound judgment in recommending solutions
- Detailed understanding of relevant vendor QMS
- Solid understanding of audit processes, planning and readiness activities
- Advanced ability to work effectively across functions & negotiate effective resolution to findings
- Strategic thinking; ability to analyze opportunities and issues from a broad, long-term perspective
- Competent end user of Microsoft Office software suite including Word / Excel / Outlook / PowerPoint
Preferred Qualifications
- Master’s Degree in a scientific discipline
- 5+ years of management of PV quality & end to end PV inspection 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
