Who We Are - Global Patient Safety | Amgen
Amgen’s Global Patient Safety experts are medical and scientific professionals with extensive safety and/or clinical or healthcare experience who are trained in medicinal safety, pharmacovigilance and worldwide health authority regulations relevant to medicinal product safety. Our experienced safety experts continually evaluate benefits and risks of our products across the product life cycle with the implementation of risk management plans that maximize their safe use. Our signal and risk management processes, combined with our robust safety governance framework, allow Amgen to determine if new safety information on our products (a ‘signal’) poses a risk to patients and how best to manage, mitigate and communicate the risk.
The Vice President of Global Patient Safety maintains oversight of all pharmacovigilance-related activities. Under the guidance of the Senior Vice President of Global Regulatory Affairs and Safety, the Global Patient Safety team collaborates with Regulatory Affairs to communicate product information in a timely, transparent, and accurate manner to regulatory agencies across the globe. Global Regulatory Affairs and Safety are part of the Research and Development function within Amgen.
Patient Safety across the World
Amgen is committed to the safety of our patients and safe use of our products in all countries where Amgen products are marketed. Amgen’s Global Patient Safety team executes pharmacovigilance activities in collaboration with team members located around the world, including Local Safety Officers (LSOs) who provide expertise regarding regional and country-specific regulatory requirements.
European Qualified Person for Pharmacovigilance
In compliance with European regulations, Amgen has appointed a European Qualified Person for Pharmacovigilance (EU QPPV) who acts as an advisor to Head of Global Patient Safety on all matters related to the safe use of Amgen products in the European Region. Amgen’s EU QPPV ensures compliance of our safety procedures with European regulations and acts as point of contact for regulatory authorities in Europe.