Experienced Clinical Safety Coordinator

				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.

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:

*  Bachelor's degree in Life Science area required;

*  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
			

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Medpace, Inc.

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