Job vor 9 Tagen bei Mindmatch.ai gefunden
CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] 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 [...] 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 [...] 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 [...]
