Collects and assesses adverse-event information for marketed and investigational products, manages global safety-database data, supports regulatory compliance and inspections, and answers case-report queries.
About this role
The Research and Development Scientist works in Pfizer’s DSRD nonclinical development function, supporting Japanese drug-development projects across pharmacology, drug disposition and toxicology. The role provides scientific input to project teams, connects local regulatory needs with global development strategy, and represents DSRD in discussions with authorities such as PMDA.
Responsibilities include planning Japan nonclinical R&D and risk management, monitoring global studies, and communicating progress, risks, findings and regulatory guidance. The scientist prepares and reviews IB, CTD and CTPN materials, adapts global documents to Japanese requirements, and responds to PMDA questions.
Applicants need a master’s degree or higher in medicine, pharmacy or biology, or a veterinary license. The posting requires knowledge of international regulatory guidelines and safety assessment, pharmaceutical regulatory-document skills, and experience in pharmaceutical R&D, animal experiments such as toxicology studies, and global regulatory submissions. Collaboration across matrixed and multiple-line teams is also required.
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