PMS Planning & Management Specialist

Design and plan scientifically appropriate post-marketing surveillance programs, including usage status studies, database studies, and post-marketing clinical trials based on product safety profiles and regulatory requirements. Lead preparation of key regulatory documents such as study outlines, implementation plans, analysis plans, clinical study reports, and periodic safety reports. Collaborate with internal stakeholders across development, medical, safety, and regulatory affairs to ensure aligned, compliant, and effective PMS execution. Engage directly with regulatory authorities to negotiate study designs, respond to inquiries, and manage consultations for timely agreements. Oversee the full lifecycle of PMS studies through robust project management, from planning and implementation through data analysis, results evaluation, and regulatory reporting. Support re-examination application conformity investigations and address emerging regulatory or operational challenges. Fluency in Japanese and business-level English required; location Tokyo, Japan.