Associate Patient Support Program Safety & PV Oversight Director
United Therapeutics Corporation
August 16, 2026
On-site
Morrisville, NC
Medical Affairs
Responsibilities:
- Provide safety governance and oversight for safety data exchanged by UTC Patient Support Programs (PSPs) across products/devices and life cycles; influence strategy for business/regulatory issues and support inspection readiness.
- Define and maintain quality/compliance standards for UT Cares adverse effect reporting; ensure unified data exchange procedures and that PM adverse effects are collected, documented, and exchanged per SOPs/industry standards.
- Create and execute project plans to improve process efficiencies and support business goals.
- Ensure compliance with global safety data collection regulations/guidelines and end-to-end case management best practices.
- Serve as primary day-to-day escalation point for adverse effect reporting questions; lead KPI/compliance discussions with UT Cares management/PSPs.
- Develop and deliver training/materials for AE/PC/SRS collection and reporting.
- Oversee and resolve PSP reconciliation discrepancies to maintain compliance.
- Lead inspection/audit activities for data exchange and GVP processes; perform root-cause analysis and ensure CAPA/deviations are approved.
Minimum Requirements:
- BS/BA in healthcare or life sciences.
- 12+ yrs PV (ICSR end-to-end) with Bachelor’s; or 10+ yrs with Master’s; or 7+ yrs with PharmD/international equivalent.
- 5+ yrs management/oversight of a call center.
- Microsoft Office (spreadsheets/email); Argus safety database experience.
- Strong GvP and QMS documentation knowledge; independent problem-solving; stakeholder influence; team collaboration; ICSR processing/PV call center management.
Preferred Qualifications:
- BSN; Master’s; PharmD.
- 3+ yrs product development/postmarketing drug experience; 2+ yrs functional lead/people management.
- RN licensure (state/compact).
Benefits:
- Eligible employees may participate in medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off/paid parental leave, and disability benefits.
Job Location:
- Fully onsite; Morrisville, NC.
- Provide safety governance and oversight for safety data exchanged by UTC Patient Support Programs (PSPs) across products/devices and life cycles; influence strategy for business/regulatory issues and support inspection readiness.
- Define and maintain quality/compliance standards for UT Cares adverse effect reporting; ensure unified data exchange procedures and that PM adverse effects are collected, documented, and exchanged per SOPs/industry standards.
- Create and execute project plans to improve process efficiencies and support business goals.
- Ensure compliance with global safety data collection regulations/guidelines and end-to-end case management best practices.
- Serve as primary day-to-day escalation point for adverse effect reporting questions; lead KPI/compliance discussions with UT Cares management/PSPs.
- Develop and deliver training/materials for AE/PC/SRS collection and reporting.
- Oversee and resolve PSP reconciliation discrepancies to maintain compliance.
- Lead inspection/audit activities for data exchange and GVP processes; perform root-cause analysis and ensure CAPA/deviations are approved.
Minimum Requirements:
- BS/BA in healthcare or life sciences.
- 12+ yrs PV (ICSR end-to-end) with Bachelor’s; or 10+ yrs with Master’s; or 7+ yrs with PharmD/international equivalent.
- 5+ yrs management/oversight of a call center.
- Microsoft Office (spreadsheets/email); Argus safety database experience.
- Strong GvP and QMS documentation knowledge; independent problem-solving; stakeholder influence; team collaboration; ICSR processing/PV call center management.
Preferred Qualifications:
- BSN; Master’s; PharmD.
- 3+ yrs product development/postmarketing drug experience; 2+ yrs functional lead/people management.
- RN licensure (state/compact).
Benefits:
- Eligible employees may participate in medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off/paid parental leave, and disability benefits.
Job Location:
- Fully onsite; Morrisville, NC.