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CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] 63a of German Medicine AMG, 12, 19 AMWHV as and when required. Responsible for the establishment, maintenance, and oversight of local Pharmacovigilance (PV) processes, including but not 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 providers, etc. ) . Regular screening of local literature, ensuring that all identified safety information is managed in accordance with local and global processes. Maintains up-to-date information relevant for the Pharmacovigilance System Master File (PSMF) or local PSMF as required by local regulations. Oversight of the submission status of aggregate reports (e. g. , PSURs) 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 [...] 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 of their PV reporting obligations. This includes development of training materials with IPV, delivery of regular and ad-hoc training, and monitoring of training compliance. Your Skills and Experience Degree in life science, nursing, pharmacy, or other related area; OR Equivalent experience Qualification in line with relevant local legislation Experience in the pharma industry, and knowledge in pharmacovigilance; OR Equivalent experience in line with relevant local legislation Good verbal and written communication skills in English Fluent in local language (s) of territory if required by legislation Travel [...]
