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Patient Safety Specialist
hace 2 meses
- Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow up on adverse reports.
Job Description Major Accountabilities
~ Apoyar la gestión de los procesos operativos para garantizar el cumplimiento de los procedimientos globales/locales de Novartis, las regulaciones/normas/directrices nacionales e internacionales para la farmacovigilancia de los productos comercializados e investigacionales de Novartis
~ Gestione la recopilación, el procesamiento, la documentación, la presentación de informes y el seguimiento de todos los informes de eventos adversos (AE) para todos los productos de Novartis de ensayos clínicos, estudios posteriores al marketing (PMS), programas orientados al paciente (POP), registros y todos los informes espontáneos (SR).
~ Transcribir, traducir (cuando sea necesario) e introducir datos de todos los eventos adversos graves (de ensayos clínicos, ) y todos los eventos adversos (desde POPs, PMS, registros y todos los SRs) desde documentos de origen hasta sistemas de seguridad con precisión y coherencia con énfasis en la puntualidad y la calidad.
~ Registros y seguimiento de recibos, envíos y distribuciones de documentos como EFS, SRs, Notificaciones de Investigadores, etc. en cooperación con otros departamentos
~ Gestionar la presentación/presentación/distribución de informes de seguridad/actualizaciones/información a las autoridades sanitarias locales y/o operaciones clínicas en cooperación con otros Departamentos.
~ Trabaje con otros asociados fotovoltaicos locales/globales para garantizar una evaluación precisa de los datos de seguridad.
~ Interactúe e intercambie información de seguridad relevante con LHA, asociados fotovoltaicos, otros grupos funcionales y contratistas externos, si corresponde.
~ Encuestar y supervisar las regulaciones de farmacovigilancia globales/ regionales/nacionales (según corresponda) y proporcionar actualización a la organización mundial de PVO.
~ Desarrollar, actualizar e implementar procedimientos locales para garantizar el cumplimiento de los procedimientos globales y los requisitos nacionales de la OPV.
~ Gestión y mantenimiento de todas las bases de datos PVO asignadas relevantes, si procede.
~ Desarrollar y actualizar materiales de capacitación para farmacovigilancia
~ Garantice el soporte y el cierre de auditorías, las actividades correctivas del plan de acción y las inspecciones de la Autoridad de Salud.
~ Proporcionar información oportuna y relevante a los coordinadores de juicios, CRAs y otro personal de Novartis
~ Distribución de muestras de comercialización (cuando proceda)
Key Performance Indicators
Monitorea y audita el programa de vigilancia de medicamentos, productos biológicos o dispositivos médicos de la compañía, incluida la ingesta, evaluación, procesamiento y seguimiento de informes adversos.
Informa eventos o reacciones según lo requieran las agencias reguladoras, incluidos los datos de eventos adversos de ensayos clínicos, fuentes espontáneas o solicitadas, informes periódicos y de experiencia.
Puede proporcionar detección y evaluación de tendencias y señales de seguridad. Apoya toda la actividad de ensayos clínicos y post comercialización.Work Experience
~Gestión y ejecución de operaciones
~Colaboración internacional
~Amplitud funcional
Skills
~Presentación (Documentos)
~Farmacovigilancia
~Ciencia de la seguridad
~Bases
~Capacitación de empleados
~Informes
Language
Inglés
Skills Desired
Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science
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