Job vor 7 Tagen bei Mindmatch.ai gefunden
CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] and the reporting of signals and urgent safety information to local regulatory authorities as required. Providing guidance to direct reports on the execution of local PV processes. Acts as a primary point of contact for all PV-related matters in their
territory/ region, and timely communication and escalation of PV-relevant issues as per established local and global processes. Responsible for ensuring awareness and compliance with current PV regulations and guidelines. Oversees the local assessment, communication, and implementation of new or updated PV requirements, including notifying Global of local reporting obligations to ensure the Global Safety Database remains 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 DQA) and Clinical. Maintains up-to-date understanding of safety [...] 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, ensuring pharmacovigilance obligations are incorporated into PVAs as needed in collaboration with GPAA. Key PV point of contact for local PV inspection by competent Regulatory Authorities and/or PV affiliate audits in the territory, in 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 personnel and personnel of relevant 3rd party service providers, ensuring these personnel are aware [...]
