Associate Director, Global PV Product Complaints

United Therapeutics Corporation; Durham (NC); Hybrid; USD 140,000 - 210,000; Full time

Job summary

United Therapeutics Corporation seeks an Associate Director, Global PV Product Complaint Management & Oversight in a hybrid role based in Durham, NC. You will lead and optimize the global product complaint governance across drugs, devices and biologics, ensuring rigorous compliance and timely safety reporting.

You will design and implement harmonized procedures, train teams, and manage inspections, CAPAs, and regulatory submissions to support the global safety surveillance program.

Qualifications

• 12+ years in pharmacovigilance or product complaint handling in global environments.

Responsibilities

• Lead global product complaint governance across drugs, devices, combination products and biologics.
• Establish and maintain SOPs, policies, and risk-based oversight models for PC handling.
• Coordinate training, inspections, and CAPA programs with internal partners and vendors.
• Oversee daily PC operations within GSD, QMS, and MDR reporting workflows.
• Evaluate regulatory changes and implement process or system updates to maintain compliance.

Skills

Pharmacovigilance

GVP governance

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in a related field

Master’s or PharmD (preferred)

Tools

Argus

Job description

United Therapeutics Corporation seeks an Associate Director, Global PV Product Complaint Management & Oversight in a hybrid role based in Durham, NC. You will lead and optimize the global product complaint governance across drugs, devices and biologics, ensuring rigorous compliance and timely safety reporting.

You will design and implement harmonized procedures, train teams, and manage inspections, CAPAs, and regulatory submissions to support the global safety surveillance program.