【AstraZeneca】【R&D】Safety Evidence Lead, 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: 

PS Evidence Lead (PSEL) serves as the Study Lead for Post Authorization Regulatory Commitment Studies (PARCS), accelerating the generation of valuable real-world evidence and the use of real-world data for safety evidence generation. PSEL is responsible for the methodological reliability and scientific robustness at all stages of responsible research concerning use-result studies/Post-Marketing Surveillances (PMS), from study planning and execution to study reporting and dissemination. PSEL demonstrates leadership in the management of the PARCS project portfolio, standardization of operational processes, and the formulation of long-term strategies for outsourcing within the GPSP organization. Additionally, PSEL supports capability development while facilitating the work of team members.

Accountabilities/Responsibilities: 

■Strategic Evidence Planning

PSEL 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

PSEL, as the Study Lead for PMS, creates clinical study protocols (CSPs) based on PVP strategies, conducts feasibility assessments for PARCS, and leads the technical review and approval of PMS-CSPs within the global governance related to evidence generation. PSEL also leads vendor selection and contract negotiations, engages with internal and external stakeholders, and oversees the preparation of interim and final reports. Additionally, they lead the planning and execution of external presentations, GSPS compliance investigations, and re-examination applications. PSEL collaborates with external service providers (ESPs) to manage the operational governance of primary studies, ensuring that all deliverables are completed on time and in accordance with relevant standards.

■Leading GPSP organization as a manager

PSEL, in collaboration with the GSPS Director, manages the PARCS project portfolio to ensure the quality and timely delivery of outputs. Additionally, PSEL is responsible for advancing daily operations and fostering the development of team members' skills within the GPSP organization. Furthermore, PSEL contributes to the transformation of the GPSP organization by leading the standardization of operational processes and formulating long-term strategies for outsourcing. This is done to address internal and external changes related to the development of the company's business strategy, such as the expansion of the R&D pipeline, regulatory trends, and guidance on evidence generation in therapeutic areas.

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

【経験 / Experience】

＜必須 / Mandatory＞

·Qualified degree in Pharmacy/ Medical/ Science

·Prior work experience as a scientist for clinical development, medical affairs or patient safety in the industry.

·Understanding of relevant regulations such as GVP/GPSP

·Understanding of PMS and DB study planning

·Scientific knowledge sufficient to understand all aspects of patient safety

·Project Management skill

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

·Results Focused – ability to overcome obstacles and achieve key outcomes.

·Analytical Thinking - Logically breaking situations or issues into their essential elements.

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

＜歓迎 / Nice to have＞

·Advanced degree, e.g. MS, MPH or PhD in science related discipline

·Extensive Pharmacovigilance Knowledge

·Problem-solving, Influencing, and Conflict Resolution skills.

·Logical thinking

·Problem solution skill

·Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas.

·Carrying out diagnosis and developing solutions.

【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