Sofie Walenbergh, Phd Email & Phone Number

Amsterdam, Noord-Holland, Nederland

National contact person for Gilead Sciences Belgium, Netherlands, Luxembourg & Kite Pharma EU B.V. Responsible for continuous compliance of the Pharmacovigilance (PV) Quality Management System following Gilead PV processes and following current (inter)national regulations.

Amsterdam, North Holland, Netherlands

Breda, Noord-Brabant, Nederland

National contact person for Amgen B.V. The Netherlands

Breda Area, Netherlands

Responsible for continuous compliance, inspection-readiness and maintaining a high standard of quality of all Amgen Pharmacovigilance (PV) processes in the Netherlands following current (inter)national regulations. This includes timely internal and external (periodic) reporting of adverse events of marketed Amgen products and clinical trial cases as well as the distribution of local risk communication (DHPC, DIL, aRMM). Responsible for case management of approximately 5,000 cases on a yearly basis. Ensure that all Amgen staff, as well as all our vendors (third parties), are safety-trained according to the current local safety procedures. - Additional responsibilities:Leading and coordinating the COVID-19 crisis outbreak team for the Dutch Affiliate (+/- 160 employees) and leading the development of business resilience procedures of the Dutch Affiliate in order to minimize disruptions as much as possible to the business and its goal to serve patients during various disaster scenarios. Key achievements:- Pivotal role as company representative in successful Pharmacovigilance (GVP) Inspection conducted by the Dutch Health and Youth Care Inspectorate (IGJ) - Leadership role as Business Resiliency Lead for the Dutch Affiliate (+/- 160 employees) assigned to me within two years after starting at Amgen - Coordinating the COVID-19 crisis outbreak as an Incident Management Team Lead for the Dutch Affiliate - Expanded responsibilities within patient safety by serving as an international subject matter expert and as LSO product specialist for Kyprolis (Carfilzomib)

Nijmegen Area, Netherlands

Responsible for the signal management and completion of periodic safety reports of a variety of post-marketing drugs in the areas of oncology, depression and osteoporosis. Ensuring accurate collection, processing and evaluation of adverse events from scientific literature publications based on the latest product information and risk management plans (RMPs). Responsible for conducting signal management on line listings to validate and prioritize adverse events. Writing periodic safety reports (PSURs and renewals), including evaluation of the risks and benefit-risk considerations, followed by timely submission of these reports to Regulatory Authorities.

Dept. Of Molecular Genetics

Responsible for the design, execution and data analysis of various in vitro, in vivo and translational research experiments, followed by writing complete manuscripts and ensure publication of these manuscripts in scientific journals. Conducting several teaching activities as being a tutor, supervisor, trainer and mentor for Bachelor and Master students at Maastricht University.Key achievements: - Successful completion of PhD within 4 years- Published 20+ first author and co-author publications- Awarded as best pitcher and best young investigator at medical scientific conferences - Co-inventor on a patent application- Co-organizer of an international liver conference - Served as chairwoman at various scientific conferences

Doctor Of Philosophy (Phd), In The Field Of Hepatology

Msc, Clinical Molecular Sciences

Bsc, Applied Sciences