Senior PV & Safety Governance Director

Unither Pharmaceuticals; Morrisville (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401k and ESPP savings plans

Paid time off

Job summary

United Therapeutics is seeking an Associate Patient Support Program Safety & PV Oversight Director to lead safety data exchange and governance across PSPs and GPS. This role shapes strategy, ensures compliance, and drives efficiency in adverse event processing.

The ideal candidate has 12+ years in pharmacovigilance, strong GVP knowledge, and proven leadership in PV call centers, QA, and regulatory activities. Onsite Morrisville, NC.

Qualifications

• Bachelor’s degree in health care or life sciences; advanced degree preferred.
• Extensive pharmacovigilance experience with end-to-end case processing.
• Experience in safety data exchange and ICSR processing.
• Strong knowledge of GVP, QA documentation, and regulatory guidelines.
• Leadership experience with call centers or PV teams is a plus.

Responsibilities

• Provide strategic direction for safety data management across PSPs and GPS.
• Oversee safety governance, inspection readiness, and regulatory compliance.
• Guide global PV processes and documentation to support risk/benefit assessments.
• Serve as main contact for internal stakeholders and PSPs on adverse event reporting.
• Develop training materials for AE, PC, and SRS data collection per SOPs.

Skills

Pharmacovigilance

GVP compliance

Quality assurance

Stakeholder management

Team leadership

Regulatory guidance

ICSR processing

Education

Bachelor's degree in health care or life sciences

PharmD

BSN

Master's degree in health care or life sciences

Tools

Argus Safety

MS Office

Document management systems

Job description

United Therapeutics is seeking an Associate Patient Support Program Safety & PV Oversight Director to lead safety data exchange and governance across PSPs and GPS. This role shapes strategy, ensures compliance, and drives efficiency in adverse event processing.

The ideal candidate has 12+ years in pharmacovigilance, strong GVP knowledge, and proven leadership in PV call centers, QA, and regulatory activities. Onsite Morrisville, NC.