Mitsubishi Tanabe Pharma America
Epidemiologist
Mitsubishi Tanabe Pharma America, Jersey City, New Jersey, United States, 07390
Entrepreneurial Spirit, Rooted in Tradition.
At Mitsubishi Tanabe Pharma Development America (MTDA), we have a storied reputation spanning over 300 years. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with a global presence and is among Japan's oldest and most respected companies. As a relatively new entrant to the U.S. market, Mitsubishi Tanabe Pharma Group's innovative compounds have already achieved commercial success through our U.S. partners. We are now preparing to launch new compounds under our own MT Pharma America label. To support this strategy, we are building a new commercial organization and expanding our functions. Job Description
Develop and update safety signal detection and management documents for global developmental and marketed products to support signal detection activities and safety evaluation. Review and develop epidemiology sections and papers for conferences and peer-reviewed journals as assigned. Support the development of epidemiological assessment strategies and safety surveillance instruments in coordination with Biostatistics. Participate in the planning, design, execution, or contribution to observational and interventional studies for global products. Develop epidemiological assessment and safety surveillance plans for assigned projects. Review epidemiology data supporting risk management plans and safety documents. Contribute to the design, implementation, and management of safety studies and clinical trials. Review epidemiological data and safety literature for safety submissions. Prepare epidemiology sections of investigator’s brochures, risk management plans, safety reports (DSUR, PSUR), and respond to health agency inquiries. Perform safety data evaluation and risk assessments for drug products. Contribute to safety meeting materials for various safety committees and groups. Provide epidemiology input to safety and evaluation meetings. Perform other departmental duties as assigned. Qualifications
Education:
Graduate degree (PhD, MD, MS, MPH) in a relevant field is required. Doctoral degree with at least 2 years of industry, academia, or regulatory experience; or Master’s degree with 6+ years of relevant experience, including 1-2 years in biopharma or medical device industry. Professional Experience:
Experience in public health, pharmacy, health outcomes research, epidemiology, biostatistics, or related fields. Familiarity with epidemiology research strategies and drug development phases. Experience in scientific writing, clinical trials, and secondary data analysis. Knowledge and Skills:
Strong research methodology, statistics, technical writing, and literature review skills. Excellent communication, presentation, critical thinking, and problem-solving skills. Ability to manage multiple projects and analyze safety data. Knowledge of analysis techniques for secondary data and experience with statistical packages like SAS or STATA. Ability to produce consistent, high-quality deliverables. Additional Information
Our Value Proposition: Enjoy a fast-moving, entrepreneurial environment similar to a small biotech, combined with the benefits of a global pharmaceutical company. Mitsubishi Tanabe Pharma Development America offers unparalleled career opportunities and supportive employee benefits.
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At Mitsubishi Tanabe Pharma Development America (MTDA), we have a storied reputation spanning over 300 years. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with a global presence and is among Japan's oldest and most respected companies. As a relatively new entrant to the U.S. market, Mitsubishi Tanabe Pharma Group's innovative compounds have already achieved commercial success through our U.S. partners. We are now preparing to launch new compounds under our own MT Pharma America label. To support this strategy, we are building a new commercial organization and expanding our functions. Job Description
Develop and update safety signal detection and management documents for global developmental and marketed products to support signal detection activities and safety evaluation. Review and develop epidemiology sections and papers for conferences and peer-reviewed journals as assigned. Support the development of epidemiological assessment strategies and safety surveillance instruments in coordination with Biostatistics. Participate in the planning, design, execution, or contribution to observational and interventional studies for global products. Develop epidemiological assessment and safety surveillance plans for assigned projects. Review epidemiology data supporting risk management plans and safety documents. Contribute to the design, implementation, and management of safety studies and clinical trials. Review epidemiological data and safety literature for safety submissions. Prepare epidemiology sections of investigator’s brochures, risk management plans, safety reports (DSUR, PSUR), and respond to health agency inquiries. Perform safety data evaluation and risk assessments for drug products. Contribute to safety meeting materials for various safety committees and groups. Provide epidemiology input to safety and evaluation meetings. Perform other departmental duties as assigned. Qualifications
Education:
Graduate degree (PhD, MD, MS, MPH) in a relevant field is required. Doctoral degree with at least 2 years of industry, academia, or regulatory experience; or Master’s degree with 6+ years of relevant experience, including 1-2 years in biopharma or medical device industry. Professional Experience:
Experience in public health, pharmacy, health outcomes research, epidemiology, biostatistics, or related fields. Familiarity with epidemiology research strategies and drug development phases. Experience in scientific writing, clinical trials, and secondary data analysis. Knowledge and Skills:
Strong research methodology, statistics, technical writing, and literature review skills. Excellent communication, presentation, critical thinking, and problem-solving skills. Ability to manage multiple projects and analyze safety data. Knowledge of analysis techniques for secondary data and experience with statistical packages like SAS or STATA. Ability to produce consistent, high-quality deliverables. Additional Information
Our Value Proposition: Enjoy a fast-moving, entrepreneurial environment similar to a small biotech, combined with the benefits of a global pharmaceutical company. Mitsubishi Tanabe Pharma Development America offers unparalleled career opportunities and supportive employee benefits.
#J-18808-Ljbffr