RWE Specialist

RWE Generation Partnering募集要項

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Job title: RWE Specialist

Location: Japan, Tokyo

Approximately 40% Remote work

Job type: Permanent

About the Job

Our team

開発品、製品におけるメディカルニーズ、Data Gapを踏まえたClinical Question/ Research questionをメディカルマネジャーと検討し、科学的に適切な研究デザインの立案、データソースの選定、解析の計画と実施、論文化を含む研究結果の報告を専門家として支援 医薬品リスク管理計画書の安全性検討事項に基づくClinical Question/ Research questionに対し、社内外の専門家とのコミュニケーションをリードし、科学的に適切な研究デザインの立案、データソースの選定、解析の計画と実施、報告書の作成を専門家として支援 外部データサイエンティストとのネットワークを構築し、高い専門性を生かしてリアルワールドエビデンスの創出を推進 日本の医療情報データベースに関する情報集積及び社内に存在する医療情報データベースの一元管理を行うと共に、医療情報データベースへのアクセスツールを用いた社内ステークホルダーへのRWD情報の提供

Our team

Discuss clinical questions/ research questions with the medical manager based on the medical needs and the data gap of the products, and support the development of scientifically appropriate research design, selection of data sources, planning and implementation of analysis, and Publication as an expert. Lead communication with external epidemiologists such as PMDA in response to clinical questions/ research questions based on safety considerations in the drug risk management plan, and development appropriate study designs, select data sources, and create and implement analysis plans. Build a network with external data scientists and promote the creation of real-world evidence by leveraging your high level of expertise Collect information on Japan's medical information database and centrally manage the medical information database existing within the company and provide RWD information to internal stakeholders using a tool to access the medical information database.

About you

Experience, Education, Soft skills and Languages

 治験または観察研究等における薬剤疫学、生物統計に関する十分な知識、5年以上の実務経験

データサイエンスやリアルワールドデータを含む医療情報データに関する十分な知識

 SAS、R、Python、SQLなどのプログラミング言語の知識と5年以上の実務経験薬機法やGPSPに関する基知識又はGxP領域での業務経験

 医薬品や疾患に関する医学的、科学的な知識と思考

 プロジェクトマネジメント、業務管理能力

 ステークホルダーとの調整やコミュニケーション能力、リーダーシップ

 英語でのコミュニケーション能力

 変化に向けて自ら行動する強い行動力と新たな手法などにチャレンジする好奇心

 Deep knowledge of pharmacoepidemiology and biostatistics in clinical trials or observational studies, DB study etc., and at least 5 years of work experience

 Knowledge of data science and technology related to healthcare data

Knowledge of programming languages such as SAS, R, Python, SQL, etc. and at least 5 years of work experience

 Knowledge of Pharmaceutical law and GPSP requirements and/or experience of GxP related activities

 Medical and scientific knowledge and thinking about pharmaceuticals and diseases

 Project management/task management ability

 Coordination and communication skills with stakeholders, leadership

 Communication ability in English

 Strong ability to take action for change and curiosity to take on new challenges

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!