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Patient Safety Specialist

hace 4 meses

Bogotá, Bogotá D.E., Colombia Novartis A tiempo completo

Summary:


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 experiência.

Puede proporcionar detección y evaluación de tendencias y señales de seguridad. Apoya toda la actividad de ensayos clínicos y post comercialización.

About the Role:

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 los eventos adversos.
~ Gestionar la 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 de vigilancia locales/globales para garantizar una evaluación precisa de los datos de seguridad.
~ Interactúe e intercambie información de seguridad relevante con la autoridad sanitaria local, asociados de vigilancia, 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 Global Pharmacovigilance Operations.
~ Desarrollar, actualizar e implementar procedimientos locales para garantizar el cumplimiento de los procedimientos globales y los requisitos nacionales de la operación de vigilancia.
~ Gestión y mantenimiento de todas las bases de datos de vigilancia 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 al personal de Novartis

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 precisa 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 experiência.

Puede proporcionar detección y evaluación de tendencias y señales de seguridad. Apoya toda la actividad de ensayos clínicos y post comercialización.

Work Experience

~ Profesional de la salud (deseable)
~Mínimo 3 años de experiência en gestión y ejecución de la operación de farmacovigilancia
~ Experiência previa en el proceso de sometimiento a través de e-Reporting

Skills:

~Buena comunicación y habilidades interpersonales
~ Orientada a calidad y resultados

~Conocimiento en la regulación nacional e internacional en materia de farmacovigilancia.

~Conocimiento en terminología médica y farmacológica

~ Habilidades en sistemas de cómputo

~ Atención al detalle y organización

Language

Inglés (B2)

Division

Development

Business Unit

Pharmaceuticals

Location

Colombia

Site

Bogota (Pharmaceuticals / GDD / NTO / CTS)

Company / Legal Entity

CO01 (FCRS = CO001) Novartis de Colombia S.A

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No