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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 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. [...] of registered and investigational products. Supports and collaborates with cross-functional teams to identify and investigate safety concerns, contributing to the evaluation of product safety risks. Participates in internal meetings regarding product safety as applicable. Participates in local Commercial Operations Leadership
Team meetings as required and provides input to strategic planning discussions as needed, ensuring alignment of PV activities with broader organizational objectives. Ensures appropriate pharmacovigilance oversight of all Organized Data Collection Systems (ODCS) within the territory, ensuring adherence to relevant processes. Facilitates the implementation of Pharmacovigilance Agreements (PVAs) in 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 [...] 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 Requirements:Domestic and/or international What we offer Excellent income potential and extended benefits Two additional leave days for your personal wellbeing Family services such as psychological support, legal advice, family care services and more for you and your direct family Hybrid working models For more information, please check out our global benefits below We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. Our Benefits We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global
leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity Inclusion at CSL. Do work that matters at CSL Behring 43263206 [...]
