Experienced Clinical Safety Coordinator

Medpace; Ciudad de México; Presencial; MXN 300,000 - 600,000; Jornada completa

Descripción de la vacante

Una organización de investigación clínica de servicio completo está buscando un Coordinador de Seguridad Clínica. Este rol clave en el proceso de farmacovigilancia te permitirá trabajar en un entorno colaborativo y dinámico, donde tus habilidades en la gestión de informes de seguridad y tu conocimiento de las regulaciones serán fundamentales. Con un enfoque en el crecimiento profesional y un ambiente de trabajo flexible, esta es una oportunidad emocionante para avanzar en tu carrera mientras contribuyes a mejorar la vida de los pacientes. Si tienes experiencia en seguridad de medicamentos y un fuerte compromiso con la calidad, este puesto es para ti.

Servicios

Ambiente de trabajo flexible

Paquete competitivo de compensación y beneficios

Paquetes competitivos de PTO

Caminos de carrera estructurados

Eventos de apreciación patrocinados por la empresa

Iniciativas de salud y bienestar para empleados

Formación

• 3 años de experiencia en seguridad de medicamentos y reportes a autoridades regulatorias.
• Conocimientos en GCP y terminología médica son esenciales.

Responsabilidades

• Supervisar la presentación de informes de seguridad a las autoridades competentes.
• Interactuar regularmente con otros departamentos internos.

Conocimientos

Conocimientos de Buenas Prácticas Clínicas (GCP)

Terminología médica

Atención al detalle

Fluidez en español

Experiencia en seguridad de medicamentos

Educación

Licenciatura en Ciencias de la Vida

Herramientas

Sistemas de Captura Electrónica de Datos (EDC)

Bases de datos clínicas

Descripción del empleo

Job Summary

Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

1. Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines;
2. Regular interaction with other internal departments globally and locally, such as Clinical Operations, Data Management, and Regulatory Submissions;
3. Draft study specific safety documents as required;
4. Work in a global team to distribute safety reports globally.

Qualifications

1. Bachelor's degree in Life Science area required;
2. Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology;
3. Knowledge of Electronic Data Capture (EDC) systems and other clinical databases;
4. Experience safety reporting to regulatory authorities in Spanish speaking LATAM countries;
5. Drug safety experience;
6. Knowledge of applicable safety reporting guidelines;
7. Strong attention to detail;
8. 3 years of experience of working within drug safety;
9. Fluency in Spanish.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO/AA Employer M/F/Disability/Vets