Pharmacovigilance Regulatory Reporting - Mexico

IQVIA Argentina; Ciudad de México; A distancia; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un Especialista en Reportes Regulatorios para unirse a su equipo. En este rol, serás responsable de procesar datos de seguridad y asegurar el cumplimiento de regulaciones y estándares de calidad. Trabajarás en un entorno 100% remoto, colaborando con equipos multifuncionales y profesionales de la salud para abordar problemas relacionados con proyectos. La posición es ideal para alguien con un título en ciencias de la vida y experiencia en farmacovigilancia, que valore la atención al detalle y la organización. Si buscas un desafío en un entorno dinámico, esta es la oportunidad perfecta para ti.

Formación

• Grado en ciencias de la vida requerido.
• Hasta 2-3 años de experiencia en actividades de farmacovigilancia.

Responsabilidades

• Procesar datos de seguridad según regulaciones y SOPs aplicables.
• Colaborar con equipos funcionales y profesionales de salud.

Conocimientos

Organizational Skills

Attention to Detail

Teamwork

Pharmacovigilance

Medical Terminology

Educación

Bachelor's degree in life sciences

Herramientas

Safety Databases

Descripción del empleo

Job Overview

As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities.

Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

Essential Functions

1. Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
2. Ensure compliance with quality, productivity, and delivery standards per project requirements.
3. Track cases as applicable to the project plan.
4. Identify and report quality problems to senior team members.
5. Liaise with different functional team members and health care professionals to address project-related issues.
6. Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.

Qualifications

1. Bachelor's degree in life sciences
2. Languages: Advanced level of English
3. Up to 2-3 years of experience in pharmacovigilance activities.
4. Good knowledge of medical terminology and applicable safety databases.
5. Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

Work modality: 100% home-based. Could be located in any Mexico city.