Patient safety is a mission, the only way to achieve it is by continuous vigilance.

Ravi Patel, RPh, PharmD, MBA Senior Vice President, GPS&PV and GxP Compliance

Global Product Safety and Pharmacovigilance

The World Health Organization defines pharmacovigilance (PV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Our Global Product Safety and Pharmacovigilance team is comprised of medical and scientific professionals with extensive safety and/or clinical experience in different therapeutic areas who are trained in medicinal safety, pharmacovigilance and worldwide heath authority regulations relevant to medicinal product safety. Some of our key responsibilities include:

  • Identify, collect, review, process & medically evaluate Adverse Events (AEs), Product Complaints (PCs) & Special Reporting Situation (SRS)
  • Continually evaluate the benefits and risks of our UT products across the product life cycle
  • Identify potential risks so that we can determine and implement measures to maximize the safe use of our products

Our Global Product Safety and Pharmacovigilance signal and safety risk management processes, combined with our robust safety governance framework, allows UT to determine if new safety information on our products (a "signal") poses a risk to patients and how to best manage, mitigate and communicate the risk.

The parents of a child with pulmonary arterial hypertension founded United Therapeutics Corporation (UT), so we take our commitment to patients personally. That includes an intense focus on patient safety and product quality.

We understand that adverse experiences with our products may happen, and we can’t always predict to whom they will happen to or when they will happen, which is why we value and appreciate when patients and/or healthcare professionals report their experiences to us.

To report adverse events, product complaints, and special report situations that allow us to continue to monitor the safe effective use of our products, please feel free to contact the United Therapeutics Global Product Safety and Pharmacovigilance team via a contact method below.

Call the toll free and select option 2 for reporting adverse event.

Email us by writing to the email address below.

Fax us at the number below.

+1 919-313-1297

When reporting, please provide us with the following information:

  • A complete summary of your experience
  • The name and contact information of the reporter
  • The name and contact information of the patient
  • The UT product being taken

By providing this information to United Therapeutics, we may reach out for further information.

Once the United Therapeutics Global Product Safety and Pharmacovigilance team is in receipt of your email, immediate auto-acknowledgement verifying receipt of your report will be issued.

If this acknowledgment is not received, we request that you check to ensure the correct email address was used and resend the email or inform us by writing to gdspvspecialists@unither.com for further troubleshooting.