Job vor 2 Tagen bei JobMESH gefunden
CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hessen
[...] to the relevant regulatory authorities, as well as the preparation or contribution to local aggregate reports, Risk Management Plans (RMPs) , and supporting documents where necessary. Implementation of additional risk minimization measures (aRMMs) , where applicable. PV oversight of local
digital and social media channels. Ensuring the existence and regular testing of a local PV business continuity plan. Documentation of local [...] compliant. Provides advice to management and updates controlled documents and platforms 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 ) and Clinical. Maintains [...] 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 [...]
