Senior Medical Director – Medical Safety Evaluation
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.
Responsibilities :
Management of the Medical Safety Evaluation Office (MSE) and leading all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle.Lead and chair global safety teams in the assessment of safety data, signal management, and risk management collaborating with international affiliates and MTPC corporate.Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues.As designated Global Safety Team Chair (GST Chair) for assigned products, responsible for activities including development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety.Provide oversight of medical safety evaluation for assigned global investigational products.Coordinate and contribute to medical assessment for assigned global post-marketing products.Implement and maintain an optimized system for signal detection, risk-benefit management, and safety medical evaluation.Partner with relevant internal and / or external experts to fulfill responsibilities.Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities.Provide primary liaison between global / local groups and external groups on product safety related issues.Interact extensively with regional and corporate departments to provide medical / drug safety input to clinical research, regulatory affairs, and global quality / manufacturing.Oversee data collection, processing, assessment, and preparation of annual reports and periodic reports to ensure timely submission to international regulatory agencies.Review and finalize medical assessments of safety data and related documents.Provide input to senior management regarding safety aspects of product development strategy.Support the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements.Work with the medical affairs team to build awareness of the safety of company products in the medical community.Accountable for the performance and results of the Medical Safety Evaluation Office within the Drug Safety department.Education :
Medical Degree (MD or DO), and current medical license preferred.Board Certification or equivalent in a medical specialty and significant clinical experience.Professional Experience :
Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and / or Clinical Development functions.Minimum of 5 years’ management experience leading a drug safety group in the pharmaceutical industry.Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans.Post-graduate training in clinical epidemiology and biostatistics is desirable.Ability to travel domestically & internationally as required, typically up to 30%.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.Experience in Phase II / III trials, especially with key safety activities.Experience in post-marketing / phase IV studies and surveys with key activities.Demonstrated authorship of PSUR, REMS or RMP, and DSUR.Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department.Experience with ARISg or other safety database programs.Our Value Proposition :
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical / chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
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