For our Global Safety and Pharmacovigilance department, we are looking for aRegional Safety Officer (RSO) Germany & Austria (m/f/x)R 248156Fulltime / permanentThe primary objective of the DACH (Germany and Austria) Regional Safety Officer position is to manage the local pharmacovigilance (PV) system(s) in the CSL enterprise (Behring, Seqirus and Vifor) ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety & Pharmacovigilance (GSPV) policies. This role is strictly non promotional and operates in alignment with the principles of CSLs Global Safety Governance System to ensure maintenance of the companys license to operate.The OpportunityEstablishes and maintains local PV systems in compliance with national regulations and GSPV policies. Leverages a diverse and robust set of sources including but not limited to regulatory intelligence, continuous improvement initiatives, key performance indicators (KPIs) as well as audit / inspection findings, to evolve and enhance the local PV system. Ensures comprehensive oversight of all local pharmacovigilance (PV) activities conducted at CSL, and establishes a robust framework for assessing potential risks, monitoring trends, and managing emerging issues. Maintains close liaison with the EU Q V, Graduated Plan Officer (Germany) and IPV Head of Europe. Act as the Graduated Plan Officer or deputy and fulfill the legal requirements in accordance with section 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 local PV activities in appropriate procedures and records.Storage and archiving of PV related documents and records i