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.
Performs other departmental duties as assigned
§ Medical Degree (MD or DO), and current medical license preferred
§ Board Certification or equivalent in a medical specialty and significant clinical experience
§ Minimum of 8 years pharmaceutical experience in Drug Safety, Medical Affairs, and/or Clinical Development
§ Minimum of 3 years’ experience leading a drug safety group in the pharmaceutical industry
§ Post-graduate training in clinical epidemiology and biostatistics is also desirable
Knowledge and Skills:
§ Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization
§ Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines)
§ Experience in Phase II/III trials, especially with key activities (e.g. SMMP, CRO interaction, Safety-Clinical Database reconciliation, expedited reporting, AOSE, IND update, AR, ISS)
§ Demonstrated authorship of PSUR, RMP, and DSUR
§ Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion
§ Experience with ARIS-g or other safety database programs