Associate Patient Support Program Safety & PV Oversight Director

United Therapeutics Corporation•Morrisville, NC

5d•Onsite

About The Position

The Associate Patient Support Program Safety & PV Oversight Director plays a key role in management and oversight of safety data exchanged by UTC Patient Support Programs across all products and devices, encompassing all life-cycles. This position provides strategic direction to the team and vendors with respect to changes in business practices for efficiency, quality, and compliance impacts. Overall, this role is critical in ensuring that operational aspects of the safety data collected and exchanged between PSPs and UT GPS are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products. Function as a horizontal enterprise leader supporting safety governance architecture, inspection readiness posture, and sustained regulatory compliance across the PSP landscape by influencing strategy to address internal and external business and regulatory issues; serving and being recognized as an expert within organization, both inside and outside UT GPS; anticipating potential internal and/or external business challenges or regulatory issues and recommend solutions; developing the tools and knowledge requirements necessary for the UT Cares program as it relates to pharmacovigilance; and making decisions and/or recommendations regarding significant matters related to safety related organizational practices, policies, programs, and safety compliance Operational Oversight, Quality Assurance, and Strategic Planning: Contribute to the design, development and execution of functional level strategy; define, oversee and maintain day-to-day quality and compliance standards for UT Cares staff related to adverse effect reporting; maintain unified data exchange procedures and monitor systems to ensure all PM adverse effects are collected, documented and exchanged per UT SOPs and industry standards for the UT Cares/GPS interface; initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives Regulatory Compliance and Guidance: Provide strategic guidance to ensure compliance with global regulations and guidelines for safety data collection; remain current on global regulations, guidelines and industry best practices for end-to-end case management, ensuring compliance with global regulations Stakeholder Management: Act as the main point of contact for day-to-day questions or issue escalation regarding adverse effect reporting for internal stakeholders/PSPs (i.e. patient navigators, Access and Affordability, PRSO Mgmt, etc.); participate in and/or lead strategic discussions with UT Cares Mgmt/PSPs on KPI oversight, compliance oversight, and future plans to ensure process and regulatory compliance related to GVP activities Training and Development: Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects, in accordance with SOPs, global regulations, guidelines, and conventions Reconciliation and Compliance Oversight: Oversee and resolve the PSP reconciliation process, ensuring all discrepancies are addressed and compliance is maintained Inspection and Audit Management: Act as the point of contact for inspections and audits related to data exchange and GVP management processes related to PSPs; conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings; review and approve deviations/CAPAs for any related activity as necessary Perform other duties as assigned

Requirements

Bachelor’s Degree in health care or life sciences
12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a Bachelor's Degree, or 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a Master's Degree, or 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a PharmD or international equivalent
5+ years of experience in management and oversight of a call center
Strong working knowledge of Microsoft Office Suite, spreadsheets, and e-mail
Experience with safety databases (Argus)
Strong knowledge of GvP regulation and QMS documentation requirements
Ability to think out of the box and present independent, reasoned solutions to identified safety issues
Ability to influence stakeholders, drive consensus of opinion, and meet critical regulatory & safety objectives
Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers
ICSR processing/PV call center management experience

Nice To Haves

Bachelor’s Degree in nursing (BSN)
Master’s Degree in health care or life sciences
Doctor of Pharmacy (PharmD)
3+ years of product development and/or postmarketing drug experience
2+ years of previous functional lead/people management experience
RN - Registered Nurse - State Licensure and/or Compact State Licensure

Responsibilities

Contribute to the design, development and execution of functional level strategy
Define, oversee and maintain day-to-day quality and compliance standards for UT Cares staff related to adverse effect reporting
Maintain unified data exchange procedures and monitor systems to ensure all PM adverse effects are collected, documented and exchanged per UT SOPs and industry standards for the UT Cares/GPS interface
Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives
Provide strategic guidance to ensure compliance with global regulations and guidelines for safety data collection
Remain current on global regulations, guidelines and industry best practices for end-to-end case management, ensuring compliance with global regulations
Act as the main point of contact for day-to-day questions or issue escalation regarding adverse effect reporting for internal stakeholders/PSPs (i.e. patient navigators, Access and Affordability, PRSO Mgmt, etc.)
Participate in and/or lead strategic discussions with UT Cares Mgmt/PSPs on KPI oversight, compliance oversight, and future plans to ensure process and regulatory compliance related to GVP activities
Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects, in accordance with SOPs, global regulations, guidelines, and conventions
Oversee and resolve the PSP reconciliation process, ensuring all discrepancies are addressed and compliance is maintained
Act as the point of contact for inspections and audits related to data exchange and GVP management processes related to PSPs
Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings
Review and approve deviations/CAPAs for any related activity as necessary
Perform other duties as assigned