Job am 03.04.2025 bei JobMESH gefunden
CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hessen
[...] limited to: Management of Individual Case Safety Reports (ICSRs) , encompassing their handling, reporting, and follow-up, as well as compliance oversight where applicable. Reconciliation of ICSRs with relevant internal stakeholders, such as Global Case Management, local Quality, Medical Information and
Sales Force, as well as third parties (e. g. , distributors, Medical Information vendors, Organised Data Collection Systems (ODCS) , service [...] to align with evolving regulations. Establishes good working relationships with GSPV, Global Regulatory Affairs (GRA) and local functions, such as Local Quality Officer (e. g. , for PTCs) , Marketing and Medical Affairs (e. g. , 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 [...] collaboration with LSOs, CSL QPPV, GSPV IPV, PVRQA, and relevant local functions. Ensures audit/ inspection preparation and close-out activities including the development of a CAPA plan and the close out of any audit/ inspection action items. Responsible as the follow-up
coordinator for CAPAs raised and for the close out of audit action items, where necessary. Manages PV training requirements of affiliate [...]