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Pharmaceutical Safety Officer
hace 2 semanas
ARTHADA
ARTHADA carries the talent encoded to our DNA. We have more than 20 years of Pan-European recruiting experience, successfully identifying and attracting the most talented candidates to service our business partners.
We distinguish ourselves by the flexibility facing any circumstance, the transparency in our communication, the efficiency in the service, the empathy with our partners and the passion we invest in everything we do.
Descripción de la oferta
ARTHADA, empresa líder en ofrecer servicios especializados de recursos humanos al sector farmacéutico, selecciona para una importante Multinacional Farmacéutica un/a
PHARMACEUTICAL SAFETY OFFICER
La candidatura adecuada se responsabilizará de la supervisión y evaluación médica de casos individuales o listados de productos asignados. Gestionará la seguridad de los informes agregados (PSUR, ACO, DSUR), RMP, informes de seguridad 'ad-hoc' y cualquier otro informe periódico o pregunta requerida por los reguladores. Se responsabilizará de la detección de señales, el mantenimiento de la información de seguridad y la gestión de los casos. Apoyará las actividades relacionadas con ensayos clínicos. Prestará su apoyo a "regulatory intelligence", mantenimiento del calendario PSUR y calendario de safety signal detection. Impartirá formación en farmacovigilancia a nuevos empleados y proveedores externos. Proporcionará información de seguridad en la presentación de registros (renovaciones y nuevas implementaciones). Contribuirá al mantenimiento del Sistema de Gestión de Calidad en Farmacovigilancia.
Requisitos
- Formación en Ciencias de la Salud, preferiblemente Medicina.
- Valorable formación específica en farmacovigilancia.
- Experiencia previa en farmacovigilancia en el sector farmacéutico.
- Inglés alto.