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Job Description Summary

  • Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow up on adverse reports.
Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
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.

Participa en la resolución de cualquier responsabilidad legal y en el cumplimiento de la normativa gubernamental. Garantiza una recepción, mantenimiento y evaluación precisos con el etiquetado del producto.

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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