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CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] 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 [...] ODCSs) , Commercial Operations, Research Development Quality Assurance (R DQA) and Clinical. Maintains up-to-date understanding of safety profiles 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 [...] 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 [...]
