Experienced Clinical Safety Coordinator

Medpace Holdings, Inc.

Mexico, Mexico City

Job Summary

Our Latin American activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical SafetyCoordinator to join our team! This position plays a key role inthe pharmacovigilanceprocess 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

• 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

Qualifications

• Educated to degree level, Bachelor of Science;• Demonstrate fundamental knowledge of Good Clinical Practice (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

Job posted: 2023-02-06

3
Subscribe