神戸医薬研究所薬物動態安全性研究部非臨床安全性グループ　マネージャー職 Pathologist

Company Overview
◆グローバルランキング20位以内
◆医療用医薬品、アニマルヘルス、そしてバイオ医薬品受託製造の3つの事業分野に強み
◆循環器、呼吸器、中枢神経などの幅広い疾患領域での製品力

Job Description
This position is responsible for non-clinical safety evaluations of multiple complex projects with toxicology/pathology knowledge in accordance to all applicable guidelines/regulations in close cooperation with partners and leading the interactions with Japanese regulatory agencies

Duties & Responsibilities:
• Safety assessment with high quality and within timeframe on products under development and on market
　・ Close communication with Germany and US
　・ Precise evaluation of toxicology data
　・ Play a role as an active R&D member of given projects
• Preparation of pertinent safety documents for J-NDA submission with high quality
　・ Preparation of CTD for J-submission
　・ Communication with toxicologists /pathologists
• Contribution to global non-clinical safety activity in preparation of TS in CTD
　・ Preparation of TS for global CTD
　・ Collaboration with toxicologists/pathologists
　・ Harmonization with standards
　・ Share the international workload
• Establish a reliable network with authorities and academia
　・ Establish a list of experts in toxicology in Japan
　・ Exchange information
• Align the functional activity worldwide
　・ Facilitate the international harmonization with NDSs in Biberach and Ridgefield
• Evaluation of toxicology package
　・ Toxicological evaluation of all in vitro /in vivo toxicity studies
• Pathology diagnostics and interpretation
　・ Evaluation of the pathology data from toxicity studies and carcinogenicity studies
　・ Monitor and evaluate modern technologies in the field of pathology
　・ Read slides and write a concise pathology report on non-GLP toxicity studies
　・ Responsible for the pathology software of the pathology data entry system

Requirements
・獣医免許
・日本毒性病理学会認定(JSTP)　
・日本獣医病理学専門家協会(JCVP)　
・Required Capabilities (Skills, Experiences, Competencies)
　・Exceptional level of knowledge in the field of responsibility(Toxicology/Pathology)
　・Negotiation skills in English / Japanese
　・Knowledge on regulatory related laws and guidelines in drug development
　・Strategic thinking
　・Board certificate in Toxicologic Pathology / Veterinary Pathology
・Language
　・Japanese: Native/Fluent
　・English:Native/Fluent
・Special Work Experience
　・>5 years experiences of working for international pharmaceutical R&D
　・Proven performance record of working in the field of responsibility (>3 drug development projects)
　・Good connection with academia and authorities

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