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CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
For our Global Safety and Pharmacovigilance department, we are looking for a Wenn Sie glauben, dass Sie für die folgende Stelle geeignet sind, bewerben Sie sich, nachdem Sie die vollständige Beschreibung gelesen haben. Regional Safety
Officer (RSO) Germany Austria (m/f/x) R-248156 Fulltime/ permanent The 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 Opportunity Establishes 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 [...] 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 [...]