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Global Product Safety and Pharmacovigilance

GPS GV

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 can 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 report their experiences to us.

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 evaluating the benefits and risks of our UT products across the product life cycle
  • •  Identifying potential risks so that we can and 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 on our products (a ‘signal’) poses a risk to patients and how to best manage, mitigate and communicate the risk.

To report an AE, PC or SRS and allow us to continue to monitor the safe and effective use of our products, please feel free to call at +1 866-458-6479 (toll free & select option 2 for reporting adverse event), or email us by writing to DrugSafety@Unither.com or send us a fax at +1 919 313 1297. When reporting, please provide us with a complete summary of your experience, and be sure to include the name and contact information of the reporter, the name and contact information of the patient, and the UT product being taken. By providing this information to UT, UT may reach out to you and/your physician for further information.

Once UT Global Product Safety and Pharmacovigilance department 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 trouble shooting.