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CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hessen
For our Global Safety and Pharmacovigilance department, we are looking for a Wenn Sie glauben, dass Sie für die folgende Stelle geeignet sind, bewerben Sie sich, nachdem Sie die vollständige Beschreibung gelesen haben. Regional Safety
Officer (RSO) Germany Austria (m/f/x) R-248156 Fulltime/ permanent The primary objective of the DACH (Germany and Austria) Regional Safety Officer position is to manage the local pharmacovigilance (PV) system (s) in the CSL enterprise (Behring, Seqirus and Vifor) ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety Pharmacovigilance (GSPV) policies. This role is strictly non-promotional and operates in alignment with the principles of CSLs Global Safety Governance System to ensure maintenance of the companys license to operate. The Opportunity Establishes and maintains local PV systems in compliance with national regulations and GSPV policies. Leverages a diverse and robust set of sources including but not limited to regulatory intelligence, continuous improvement initiatives, key performance indicators (KPIs) [...] , for ODCSs) , Commercial Operations, Research Development Quality Assurance (R DQA) and Clinical. Maintains up-to-date understanding of safety profiles of registered and investigational products. Supports and collaborates with cross-functional teams to identify and investigate safety concerns, contributing to the
evaluation of product safety risks. Participates in internal meetings regarding product safety as applicable. Participates in local Commercial Operations Leadership Team meetings as required and provides input to strategic planning discussions as needed, ensuring alignment of PV activities with broader organizational objectives. Ensures appropriate pharmacovigilance oversight of all Organized Data Collection Systems (ODCS) within the territory, ensuring adherence to relevant processes. Facilitates the implementation of Pharmacovigilance Agreements (PVAs) in close collaboration with the relevant Global Safety and Pharmacovigilance (GSPV) functions and local teams e. g. Global Pharmacovigilance Agreements and Alliance (GPAA) and International Partner Markets (IPM) team. Responsible for the management and oversight of third-party subcontracted activities, maintaining local control and accountability. Conducts reviews of relevant Quality Agreements with business partners, [...]
