Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.
Manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of databases required by MTDA projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design data entry interfaces in accordance with SOPs, client requirements, and regulatory guidelines.
Provides technical support for the Drug Data Systems employed in processing and management of study safety data encompassing reporting tools for data review and Drug Safety metrics, performance and quality, generation. Resolves Drug Safety data integrity issues and addresses database design inconsistencies over time. Manages and monitors interactions with Drug Safety project specific third party vendors. Identifies process optimization to improve efficiencies. Develops and maintains standard library (global, therapeutic and client specific). Provides technical support to the Global Drug Safety Data Management staff and Project Team for existing databases, user interface, reporting tools, metrics generation and E2B / CDISC standards.
This will be a three month renewable contract position.