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Post Market Surveillance and Analyst Regulatory
hace 1 mes
**Descripción empresa**:
TRABAJAMOS CADA DÍA PARA SER UN PROVEEDOR COMPLETO PARA EL CUIDADO DE LA SALUD.
En B. Braun desarrollamos soluciones eficientes y buenas prácticas para el cuidado de la salud gracias a un diálogo constructivo con nuestros clientes y colaboradores.
A través de una estrecha relación y cooperación con los profesionales de la salud combinamos nuestros servicios y productos para ofrecer soluciones inteligentes y eficientes que cubran terapias completas y nos permitan seguir creciendo juntos.
**Misión del cargo**:
Garantizar el cumplimiento de las actividades referentes al Programa de Vigilancia Post-mercado para la compañía.
**Funciones del cargo**:
Solicitar en conjunto con el líder del departamento los documentos requeridos para realizar los trámites propios del área como la renovaciones, modificación y nuevos registros sanitarios
Elaboración de expedientes para las solicitudes de los registros sanitarios de medicamentos, dispositivos médicos, cosméticos, alimentos regulares y alimentos con propósitos médicos especiales APME bajo la coordinación del líder del departamento.
Solicitar la traducción a la empresa autorizada de los documentos técnicos y legales seleccionados para la elaboración de los expedientes.
Preparar y radicar las solicitudes de registros y presentarlas en el aplicativo establecidos por el INVIMA.
Dar respuestas a los autos emitidos por el INVIMA, bajo la coordinación por parte del líder del departamento y hacer seguimiento al trámite.
Asegurar mitigar el riesgo de cancelación y/o suspensión de registros sanitarios asegurando las acciones para evitar poner en riesgo la venta de los productos de la compañía.
Creación, modificación de los documentos en SAP de los materiales relacionados con los registros sanitarios (COI), clientes autorizados para comercializar medicamentos de control especial (COC), venta de medicamentos de BBMCO (COF), previa delegación y autorización del líder del departamento.
Diligenciamiento de los formatos para solicitud de pago ante INVIMA y traducciones, archivándolos en la carpeta correspondiente.
Actualización de la información de registros y demás documentos en las bases de datos de asuntos regulatorios cada vez que se expida algún trámite al departamento.
Recepción, análisis de la información y reporte a Casa Matriz (B. Braun Group) mediante el módulo SAP C3, reporte a INVIMA, notificación al cliente de las actuaciones relacionadas a la gestión de reclamaciones de productos a través de los programas de Farmacovigilancia y Tecno vigilancia dentro de los términos establecidos en la normatividad sanitaria aplicable y lo estipulado en casa matriz.
**Requisitos**:
1 año de experiência en Asuntos Regulatorios y 2 manejando el programa de Vigilancia Post Mercado.
Profesional en Química Farmacéutica.
**Condiciones oferta**:
