ノバルティスの安全性データベースは世界最大級の規模を持ち，日々の業務に利用されています。このデータベースから安全性情報を抽出し，当局報告等に利用 されるデータを作成するチャレンジングな業務となります。 この業務では日本国内のみならず，グローバルの同僚と協働していくことが必要であり，また毎日の業務に加え，グローバルプロジェクトに参画していくことに なります。
-End to end management of assigned pharmacovigilance processes across Novartis Divisions
-Responsible for ensuring compliance to global regulatory requirements with maximum
-Lead assigned cross functional patient safety projects
-Author and maintain procedural documents for assigned processes and drive continuous
improvement by alignment of relevant stakeholders globally and locally
-Develop and maintain training material and communications for Novartis group and third
-Support impact assessments on emerging regulations and ensure ongoing compliance to
global regulatory requirements
-Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases)
-Analyze the impact of other process and organizational changes
-Work in collaboration with other functions to produce compliance reports and complete
quality checks to monitor regulatory compliance as well as compliance to internal
requirements. In the case of any delays, investigate the root cause and develop and
implement corrective and preventative actions. Measure effectiveness of actions taken
-Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the
preparation of responses to findings and the development and implementation of corrective
and preventative actions.
-Resolve queries from other functions and Country Organizations (COs) related to assigned
processes and act as a consultant on regulatory requirements.
-Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk
Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any
-Mentor and train new starters
このポジションでは，医薬品（再生医療等製品，医療機器を含む）安全性データをArgus Safetyシステムから抽出し，安全性定期報告，再審査申請資料を作成します。 医薬品業界の経験があることが望まれますが，データマネジメント業務の経験があれば，必須ではありません。
5+ years of relevant experience in Data Science
Collaborating across boundaries
Data Management & Systems
Operations Management and Execution
Strong cross functional leadership
Working in multi-national context and across countries
Continuous Learning (Dyn. Knowledge Development)
Technical / Functional Skills & Knowledge
Data Management & Systems
Information & Knowledge Management
SAS and/or SQL programming skill for safety data management
Experience of Argus safety database
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Global Drug Development
CMO & PATIENT SAFETY GDD
Company / Legal Entity
Novartis Pharma K.K.