Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

				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:

* Working closely with the Clinical Safety Manager to ensure each project deliverables are met;

* Collect, process, and track serious adverse event (SAE) reports and clinical event documents;

* Generate and track study report safety narratives;

* Coordinate safety surveillance activities (e.g., lab review and trend analysis);

* Generate Investigator Safety Letters and distribution to health authority;

* Assist in preparation of clinical safety documents 

* Perform safety submissions of expedited/periodic reports in Singapore/Taiwan/China

Qualifications:

* Bachelor's degree in health/life sciences with 1 year of clinical safety experience or 2 years of pharmaceutical research experience;

* Proficient in a range of Clinical Safety tasks, as detailed in the 'responsibilities' section (above)

* Proficiency in verbal and written Mandrain (both simplified and traditional)
* Excellent time management skills with an ability to work on tight timelines;

* An ability to interact well within a team environment, but also work independently and manage own workload;

* Proficient in Microsoft Office and demonstrated ability to efficiently use safety database;

* Strong attention to detail;

* Demonstrate comprehensive knowledge of Good Clinical Practice (GCP) guidelines
			

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