Post Market Surveillance and Regulatory Affairs

hace 2 meses

Bogotá Cundinamarca, Colombia B. Braun Medical S.A. A tiempo completo

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 Tecnovigilancia, Farmacovigilancia dentro de los términos establecidos en la normatividad sanitaria aplicable y lo estipulado en casa matriz.
Asumir las responsabilidades asignadas del Technical Director & Regulatory Affairs Leader en sus ausencias. Back up del Regulatory Affairs Analyst para medicamentos.

**Obligaciones y responsabilidades**:

- Garantizar la correcta implementación y mantenimiento del programa de Tecnovigilancia, Farmacovigilancia, reclamaciones acorde a la legislación sanitaria vigente y procedimientos de la compañía.
- Garantizar y verificar la correcta aplicación de los procedimientos de gestión de reclamaciones, devoluciones, trazabilidad, retiro de producto de mercado y notas de aviso.
- Garantizar la correcta implementación del programa de trazabilidad de dispositivos médicos activos (equipos biomédicos).
- Garantizar la correcta implementación de la trazabilidad de los dispositivos médicos implantables.
- Mantener al día y organizado los registros y la documentación de Tecnovigilancia, Farmacovigilancia, reclamaciones, retiros de productos del mercado (Recall) y notas de aviso.
- Coordinar las notas de aviso y notificaciones de recall
- Proponer y hacer seguimiento a las acciones que se deriven de los procesos de Tecnovigilancia, Farmacovigilancia, reclamaciones de producto, devoluciones, retiros de productos del mercado (Recall) y Notas de Aviso.
- Elaborar los reportes y análisis de datos para propuesta de acciones acorde a los reportes de incidentes y eventos adversos relacionados con los medicamentos, dispositivos médicos, cosméticos, alimentos por la compañía.
- Realizar el levantamiento, implementación y seguimiento de las acciones correctivas y/o preventivas pertinentes, que garanticen la minimización del impacto de las reclamaciones de producto, devoluciones, retiros de productos del mercado (Recall) y Notas de Aviso.
- Responsable de llevar la gestión y análisis de riesgos derivados de las reclamaciones procedentes del cliente.
- Participar activamente en la revisión de los análisis de riesgos.
- Conocer y cumplir los procedimientos y normas que regulan las actividades propias del área.
- Apoyar el cumplimiento de las actividades planeadas referentes a la radicación de los expedientes de registros sanitarios presentados ante el INVIMA, de acuerdo con la programación del Departamento de Asuntos Regulatorios, asesoría técnica a los departamentos de la compañía que lo requieran, asegurando que todos los productos bajo su responsabilidad cuenten con los respectivos registros sanitarios y/o permisos de comercialización y demás responsabilidades del cargo.

**Competencias profesionales**:

- Profesional en Química Farmacéutica.
- 1 año de experiência en roles similares en el área regulatoria o afines /Gestión de reclamaciones / Farmacovigilancia y Tecnovigilancia.
- Inglés B2.

**Competencias personales**:

- Aprende activamente.
- Coopera constructivamente.
- Actúa con enfoque al cliente.

**Nuestra oferta**:
Ven a formar parte de una cultura cuyo lema es Sharing Expertise: desarrollar soluciones eficientes a través de un diálogo constructivo con profesionales de la sanidad y pacientes. Trabaja en B. Braun para proteger y mejorar la salud de las personas en todo el mundo. Podemos ofrecerte tareas interesantes y variadas, y oportunidades excelentes para progresar, así como un salario atractivo con amplias ventajas, todo ello en una empresa familiar y sostenible.

**Fecha límite**:
14.09.2024

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