Global PV Product Complaints Director - Oversight & Strategy

United Therapeutics Corporation; Durham, Northern (NC, KY); Hybrid; USD 130,000 - 170,000; Full time

Job summary

United Therapeutics Corporation seeks an Associate Director to lead Global PV Product Complaint Management & Oversight. This role directs global safety governance for products throughout life cycles, ensuring robust documentation, evaluation, and decision-making to support benefit/risk management.

Responsibilities include designing harmonized procedures, training, and KPI monitoring, plus cross-functional collaboration to maintain inspection readiness and ensure compliance with FDA, EMA, and

Qualifications

• 10+ years in pharmacovigilance, end-to-end case processing of ICSRs or product complaints.
• Experience with devices, biologics, drug products, and/or combination products.
• Strong knowledge of GMP, QSR, ISO 13485, ISO 14971 and IMDRF guidelines.

Responsibilities

• Lead global Product Complaint Safety governance across drugs, devices, and biologics.
• Develop and maintain global PC process framework, SOPs, and escalation paths.
• Oversee inspection readiness, audits, and CAPA implementation.
• Direct and manage PV staff, vendor oversight, training, and performance.
• Ensure compliance with 21 CFR 211/820, EU MDR, IMDRF and ISO requirements.

Skills

Pharmacovigilance leadership

Regulatory compliance

Risk assessment & management

Project coordination

Cross-functional collaboration

Education

Bachelor’s in a related field

Master’s degree or PharmD preferred

Certifications in PV or QA (preferred)

Tools

Argus (safety database)

MedDRA coding

PV regulatory knowledge tools

Job description

United Therapeutics Corporation seeks an Associate Director to lead Global PV Product Complaint Management & Oversight. This role directs global safety governance for products throughout life cycles, ensuring robust documentation, evaluation, and decision-making to support benefit/risk management.

Responsibilities include designing harmonized procedures, training, and KPI monitoring, plus cross-functional collaboration to maintain inspection readiness and ensure compliance with FDA, EMA, and