【AstraZeneca】【R&D】Patient Safety Epidemiologist, 研究開発本部 ﾍﾟｲｼｪﾝﾄ ｾ-ﾌﾃｨ統括部 ﾍﾟｲｼｪﾝﾄｾｰﾌﾃｨｴﾋﾟﾃﾞﾐｵﾛｼﾞｰ＆ｴﾋﾞﾃﾞﾝｽｼﾞｪﾈﾚｰｼｮﾝ部

About this role

■職務内容 Description: The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database study and use-result survey, accelerating the generation of valuable real-world evidence. Leveraging extensive clinical research expertise, including secondary data analysis, as well as various data assets and access rights held by AZKK, the PSEPI is responsible for the methodological reliability and scientific robustness at all stages of responsible research, from study planning and execution to study completion and publication. As an expert in epidemiological research, the PSEPI leads the education and utilization of real-world data within the Japan Patient Safety organization and contributes to organizational development

Accountabilities/Responsibilities: Strategic Evidence Planning PSEPI contributes to the development of local Risk Management Plans (RMPs) preparing by Japan Patient Safety (PS). They start planning formulate Pharmacovigilance Plan (PVP) strategies and PARCS from the preparation stage of the new drug application (NDA) and lead discussions and consensus-building with internal stakeholders and regulatory authorities regarding PVP strategies for NDAs. Study Execution PSEPI creates study design concepts (SDC) and clinical study protocols (CSP) based on PVP strategies as the scientific lead for PARCS

They conduct feasibility assessments for PARCS and lead the technical review and approval of SDC/CSPs within the global governance related to evidence generation. In study execution and publicizing study results, the PSEPI leads regulatory processes, including epidemiological consultations, and engages with internal and external stakeholders. They oversee the execution of the analysis plan and the preparation of interim and final reports with study team members, ensuring quality by reviewing deliverables

They also support the planning and execution of external presentations and publication

Apply for this role on AstraZeneca’s official careers site.