Pharmacovigilance & Product Monitoring

Pharmacovigilance & Product Monitoring

Pharmacovigilance
The Global Pharmacovigilance Department is responsible for the collection, processing and analysis of adverse events for Mallinckrodt's pharmaceutical products in compliance with regulatory requirements. The goals of the Global Pharmacovigilance Department are to minimize or prevent harm to patients by identifying new safety concerns and/or hazards associated with Mallinckrodt medicinal products and to implement risk-minimization measures when appropriate. You may contact Global Pharmacovigilance to report any side effect / adverse drug experience related to a medicinal product. Full details on contacting Pharmacovigilance can be found here.

Product Monitoring
The Mallinckrodt Product Monitoring Department consists of healthcare and life science professionals responsible for handling the following compliance and U.S. Food and Drug Administration-regulated activities:

• Maintaining the call center for product monitoring, drug safety and medical information
• Capturing, documenting, analyzing and reviewing quality complaints for Mallinckrodt's dosage pharmaceutical and, active pharmaceutical ingredients
• Coordinating and executing product recalls and field actions
• Fielding and responding to requests for technical and medical information about nuclear medicine, contrast media, imaging device and dosage pharmaceutical products

You may contact Product Monitoring to report any quality complaint or medical device report. Full details on contacting Product Monitoring globally can be found here.