Especialista En Farmacovigilancia

Drive continuous process improvement by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation. Lead assigned PS&PV projects and support higher complexity/criticality projects led by (Senior) Vigilance Process Managers, including IT projects/systems, in alignment with the company and department strategy. Act as process owner / deputy process owner for assigned vigilance processes: ¿ Support active surveillance and analysis of emerging regulations, perform impact assessments, and drive process changes to ensure ongoing compliance to global regulatory requirements. ¿ Author and maintain the assigned processes and the associated procedural documents. ¿ Mentor and train new starters in PS&PV and participating in the creation and maintenance of training material and communications for Novartis and third-party associates. ¿ Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process. ¿ Own and maintain relevant PSMF sections and annexes. ¿ Maintain the content of Business Continuity Plans for all respective processes, including IT applications for Key Business Processes. Develop, implement and perform monitoring activities designed to ensure safety cases processed in the safety database and aggregate safety reports produced meet Novartis group standards and are produced and submitted according to Novartis internal and worldwide regulatory timelines: ¿ Collaborate with other functions to define requirements for compliance reports and identify and implement quality checks to monitor regulatory compliance as well as compliance to internal requirements. ¿ Oversee the timely implementation of corrections and performing trend analyses of the results of quality sampling, online/offline QC checks and monitoring activities. Requisitos del puesto: - Well paid. - Opportunity to belong to a BIG PHARMA company. - Flexible working hours Formación: Licenciado : Farmacia , Grado : Grado en Farmacia Idiomas: Inglés : C1 Conocimientos: farmacovigilancia , argus Experiencia: 4 años