Job vor 6 Tagen bei Mindmatch.ai gefunden
CSL Behring
Regional Safety Officer (RSO) Germany Austria (m/f/x)
• Hattersheim am Main
[...] 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 potential risks, monitoring trends, and managing emerging issues. Maintains close liaison with the EU QPPV, 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, [...] 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 [...]