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 [...] 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 [...] 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 [...]
