Who We Are
Amgen’s Global Patient Safety staff are medical and scientific professionals, with extensive training and experience who are trained in the application and science of pharmacovigilance (PV). Our safety professionals continuously monitor and evaluate the safety profile of our products (medicines, devices, and combination products) across their lifecycle and apply risk mitigation strategies that optimize the product benefit-risk profile. Our signal and risk management processes, combined with our safety governance framework, allows Amgen to determine if new safety information on our product poses a risk to patients and how best to manage, mitigate and communicate the risk to healthcare providers and patients across the globe.
The Vice President and Head of Global Patient Safety maintains oversight of all PV-related activities. Under the guidance of the Executive Vice President of Research and Development, the Global Patient Safety team collaborates cross-functionally to communicate product information in a timely, transparent, and accurate manner to patients, healthcare providers and regulatory agencies across the globe.
Patient Safety Around the World
Amgen is committed to the safety of our patients and safe use of our products. We apply global policies and standards to achieve this in all countries where Amgen products are marketed and where we conduct clinical trials. Amgen’s Global Patient Safety team executes PV activities in collaboration with team members around the world, including Local Safety Officers who provide regional and country-specific regulatory expertise. In countries with evolving PV regulations, we work with regulatory authorities to build local capabilities and stronger systems.
European Union (EU) Qualified Person for Pharmacovigilance
In the EU, Amgen has an EU Qualified Person for Pharmacovigilance (EU QPPV) who is responsible for the establishment and maintenance of Amgen’s pharmacovigilance system. The EU QPPV oversees the functioning of Amgen’s pharmacovigilance system in the region, including but not limited to standard operating procedures; contractual arrangements; database operations; and compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance. Amgen’s EU QPPV has oversight of our compliance with EU regulations and acts and serves as the Company’s point of contact for regulatory authorities in the region.
Training for Staff, Contractors and Suppliers
New Amgen staff, contractors, and suppliers are required to complete Global Patient Safety training as applicable to their role, as well as functional level role-specific training. Training includes topics associated with Amgen’s products, procedures, global regulations, and systems. Staff are required to read and certify their compliance with designated Amgen policies, procedures, and supporting documents. Global Patient Safety staff also receive systems training, eLearning modules and attend external industry courses, as needed. In addition, all Amgen staff are required to complete training on our Adverse Event and Product Complaint Reporting Corporate Policy.