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CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] 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 local PV activities in appropriate procedures and
records. Storage and archiving of PV-related documents and records in GXP validated repository. Conducting local reportability assessments 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 [...] 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 [...]
