研究開発・メディカルアフェアーズ統括本部 GPSS Pharmacoepidemiology/R1 4/Scientist/S…

【求人No NJB2224844】
主要な職務内容: Primary Responsibilities:
1. Safety Observational studyのScientific Lead
医薬品の安全性に関するリサーチクエスチョンに対し、薬剤疫学に関する調査・研究を計画・実行する（プロトコール作成、解析計画書作成、医療情報データベースや診療情報等を含むデータベースを活用した調査の実施、試験報告書、論文作成など）。

2. 医薬品リスク管理計画書作成への貢献
薬剤疫学に関する専門家として医薬品リスク管理計画書の作成に貢献する。

3. 疫学に関する専門性の発揮
医薬品開発から製造販売後の製品ライフサイクル全般に亘って安全性の観点から疫学に関連する専門性を発揮し、活動を支援する（規制当局等からの照会に対する回答作成、RWD/RWE創出の計画策定・実行、疾患病態の理解を深める為の調査など）

4. 社内関係部署との連携及び、外部顧客との協働
社内関係部署（開発チーム、Safety、Medical Affairs、Regulatory等）や外部専門家、CRO等と協働し、安全性に関連した薬剤疫学の観点から活動を支援する。

5. ファーマコビジランスに関連する活動
日本のファーマコビジランスに関連する規制やルールを理解する。薬剤疫学に関連するSafety Quality System（安全性に関連するSOP）の作成、メンテナンスを行い、関連するトレーニングを提供する。

6. 分析ツールの活用
様々なデータ（医療情報データベース、診療情報、など）や分析ツールを薬剤疫学に関する調査・研究に活用し、質の高いアウトカム提供に貢献する。


The purpose of the Global Patient Safety Solutions （GPSS） Pharmacopidemiology（Japan GPSS PE） is to provide pharmacoepidemiology leadership and technical support to the Japan Safety Organization（GPSS） and other relevant functional areas within the Company. The Japan GPSS PE has primary responsibilities for designing conducting analyzing and interpreting of pharmacoepidemiology studies using appropriate methods and data sources.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Responsible to lead safety observational studies as scientific lead and to deliver deliverables
Responsible as a study owner of regulatory mandatory safety studies under GPSP （Good Post Marketing Surveillance Practice）
Demonstrate scientific leadership in safety observational studies and ensure scientific level of study deliverables from pharmacoepidemiology perspective.
Define research questions develop study design including statistical analysis plan based on research questions evaluate and interpretate data （analyze in some cases）
Review and develop study report/publications.
Lead scientific discussion in cross functional team and in discussion with regulatory agency.
Collaborate effectively with global and Japan relevant functions and external partners （investigator CROs） so as to deliver valuable evidence.

Support non regulatory mandatory safety observational studies
Provide pharmacoepidemiology expertise to support non regulatory mandatory safety studies.
Engage in study protocol study report/publication development and ensure scientific quality from safety perspective in collaboration with relevant stakeholders.

Demonstrate pharmacoepidemiology expertise in safety related activities through product lifecycle
Provide pharmacoepidemiology expertise to support compounds in development new product launches and existing marketed products.
Contribute to Japan Risk Management Plan （RMP） development periodic report development.
Review and develop query response to regulatory authority.
Demonstrate knowledge of relevant global and local regulatory requirements and practices
Understand the roles responsibilities of the EU Qualified person for Pharmacovigilance （QPPV） and support QPPV to enable to fulfill all QPPV legal responsibilities.
Contribute to organizational RWE capability development
Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to pharmacoepidemiology.
Provide pharmacoepidemiology related trainings.
Support system/process development to enhance productivity or increase scientific quality.
Obtain up to date pharmacoepidemiology approach/knowledge