Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS) and Parkinson’s (PD)..
MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
Manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of databases required by MTDA Drug Safety projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design and program reports based on the data reporting requirement in accordance with SOPs, client requirements, and regulatory guidelines.
The Senior Safety Specialist will contribute to all activities supported by the Office of Quality, Standards, and Training (QST) within the Drug Safety department. The Senior Safety Specialist will assess the quality performance of regional Drug Safety Department, developing quality monitoring tools and performing quality assessment of assigned safety reports (Global Development and Post-marketing Products and/or local development/post-marketing products) including but not limited to reviewing clinical trial documents, Safety Monitoring Plans, safety data reconciliation documents, and other safety documents prepared for and/or affecting compliance of regulatory submission. The Senior Safety Specialist will facilitate development of standard operating procedures (SOPs) and other process-related documents (e.g., working instructions) for Drug Safety in a regional and global capacity. The incumbent will also develop and implement the regional Drug Safety department training program, maintain SOP/WIN training, and facilitate training classes (GDSEC seminars) for Drug Safety and other departments as needed.