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:
* Work closely with the Clinical Safety Manager to ensure project deliverables are met;
* Generate safety letters as applicable and submit SUSAR reports and aggregate reports to the regulatory authority in South Korea;
* Conduct quality control review of safety reports and other department documents as needed;
* Translate safety documents between Korean and English;
* Track, process, and organize various safety-related documents;
Perform other duties as assigned by the Clinical Safety department
Qualifications:
* Minimum 2 years of relevant Pharmacovigilance experience.
* Strong attention to detail.
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