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

■ 職務内容 / Job Description

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 regulatory authorities regarding PVP strategies for NDAs.

■Study Planning and Execution

PSEPI creates study design concepts (SDC) and clinical study protocols (CSP) based on PVP strategies as the scientific lead for PARCS. They identify clinical questions and structure them into research questions, decide on study design and approach, and determine plan of statistical analysis. 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 preparation of interim and final reports and lead the planning and execution of external presentations.

■Leading team as an epidemiologist

In team working, the PSEPI serves as the leader of cross-functional study teams, leveraging members' expertise to ensure the successful execution of study activities. They provide coaching to study team members to support and accelerate their performance and facilitate smooth collaboration with cross-functional company-wide teams as a representative of Japan Patient Safety. As a skills leader, the PSEPI contributes to enhancing the real-world evidence (RWE) generation capabilities of PS Evidence Generation members. They monitor changes in the external environment related to epidemiological research methodologies, available information sources, research-related technological trends, regulatory trends, and guidance on evidence generation in therapeutic areas, and lead the continuous improvement of deliverable quality by integrating these changes into company processes. As an expert in epidemiological research, they support safety risk management activities within Japan Patient Safety (JPS) and plan, execute, or support analyses using advanced epidemiological methodologies that do not fall under PARCS.

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

·MPH or MSc with equivalent experience in pharmacoepidemiology, epidemiology or related health science field.

·Strong background in epidemiological theory and methods, including appropriate use of medical statistics to solving problems in epidemiology.

·Able to provide a robust literature review and perform critical appraisals to published studies.

·Conceptual understanding of secondary data and/or primary data collection studies and they can be used to generate RWE.

·Ability to work effectively with experts from a wide variety of disciplines.

·Ethics – overriding commitment to integrity and high standards in self and others.

＜歓迎 / Nice to have＞

·Ph.D. in pharmacoepidemiology, clinical epidemiology or related health science field.

·Prior work experience as an epidemiologist in the industry or regulatory authorities.

·Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area.

·Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：ネイティブ

英語 English Business English Level

【キャリアレベル / Career Level】

E

【勤務地 / Work Location】

Osaka or Tokyo