LATAM Clinical Safety Coordinator – Pharmacovigilance

Medpace, Inc.; Ciudad de México; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Medpace is seeking a full-time, office-based Clinical Safety Coordinator to join our team in Mexico City. This role plays a key part in the pharmacovigilance process and supports global safety activities within a leading CRO.

The position involves working in a collaborative team to accomplish tasks instrumental to Medpace's success, with opportunities to develop and grow your career in a dynamic environment.

Formación

• Bachelor's degree in Life Science required.
• Fundamental knowledge of GCP guidelines and medical terminology.
• Knowledge of Electronic Data Capture (EDC) systems and other clinical databases.
• Experience safety reporting to regulatory authorities in Spanish speaking LATAM countries.
• Drug safety experience.
• Knowledge of applicable safety reporting guidelines.
• Strong attention to detail.
• 3 years of experience of working within drug safety.
• Fluency in Spanish & English.

Responsabilidades

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

Conocimientos

GCP knowledge

Attention to detail

Spanish & English fluency

Educación

Bachelor's degree in Life Science

Herramientas

EDC systems

Descripción del empleo

Medpace is seeking a full-time, office-based Clinical Safety Coordinator to join our team in Mexico City. This role plays a key part in the pharmacovigilance process and supports global safety activities within a leading CRO.

The position involves working in a collaborative team to accomplish tasks instrumental to Medpace's success, with opportunities to develop and grow your career in a dynamic environment.