General Information

Job Advert Title: Senior Manager, Data Management, Report & Analytics, Pharmacovigilance(ファーマコヴィジランス部におけるデータおよび帳票の管理)

Location: Nihonbashi, Tokyo

Division: Pharmacovigilance

Employment Class: Permanent


Purpose & Scope

Pharmacovigilance (PV) is a global organization responsible for collection, processing, evaluation, and reporting of incoming adverse event data according to worldwide regulatory guidelines/requirements, evaluation of safety signals from aggregate data, and planning and execution of safety measures. 

PV Information Management (PVIM) group is responsible for maintenance and implementation of IT systems used for various PV activities, such as safety database, in the PV organization. Senior Manager, Data Management, Report & Analytics is a position in the PVIM group and is responsible for managing development and generation of reports from PV IT systems to support various PV activities, such as periodic reports to worldwide regulatory authorities including Japan periodic reports, reports supporting aggregate safety analysis and signal evaluation, reports supporting ICSR submission compliance management, etc., and contributing to the establishment of long-term reporting strategies to identify the best reporting solutions. 

This position is mainly responsible for managing Japan local reports, but also works with a global team to address global report requirements and participates in various global projects. This position reports to a line-manager located in the US (Director, Data Management, Report & Analytics). Please note that actual development and execution of reports is done by technical resources, so this position does not require developer skills itself, but requires an ability to understand and translate business requirements into technical language so the technical resources can develop reports that meet business requirements.

PV Information Management(以下、PVIM)グループは、PV部において、安全性データベースを始め各種PV業務に使用されるITシステムの管理・導入を担当しています。
今回募集するポジション(Senior Manager, Data Management, Report & Analytics)は、様々なPV業務に必要な各種帳票(日本を含む世界各国の規制当局への定期報告、集積データ解析や安全性シグナル評価に必要な帳票、個別症例報告期限管理のための帳票等)の開発やシステムからの出力を通じてPV活動に貢献し、また将来の帳票開発に関する戦略立案にも貢献いただきます。ご担当いただくのは日本語の帳票開発が中心となりますが、グローバルチームとの連携しながらグローバル帳票要件への対応を行ったり、様々なグローバルプロジェクトに参加いただく予定です。

Essential Job Responsibilities

Ensure the design and development of JP custom reports, including J periodic reports meet the business requirements

Lead JP reporting strategy and Identify best solution for JP reports

As a safety system and report expert, help Product Responsible Person(s) in PV design the best approach for safety data analysis (data analysis & consulting)

Participate in data & reporting governance activities

Lead PV Business Intelligence activities in Japan

Work with the global team to address global report requirements and participate in global projects









    Basic PV business knowledge including ICSRs and periodic reports

    Experience working on the safety database, including report generation

    Ability to manage projects and provide oversight of report development initiatives

    Written and verbal communication skills in both Japanese and English: has an ability to communicate with colleagues and vendors in and outside of Japan (TOEIC: over 800 as a rough indication)

Ability to be actively and enthusiastically engaged in innovation




日本語と英語の読み書きと会話ができ、対面や電話会議等を通じて日本および海外の同僚やベンダーと口頭でコミュニケーションの取れる方(TOEIC 800点以上目安)



Understanding of PV business

Familiarity with regulations pertaining to adverse event reporting and periodic reporting, including PMDA and global requirements

Understanding of system validation

Skills of business analysis and requirement definition for safety data system

Safety Database and its configurations

Design and validation of IT report








Advanced degree (MA and/or PhD or related degree) is preferred.

SQL programming


SQL プログラミング

【勤務地 / Location

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

【勤務開始日 / Start Date


Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration


Not limited to specified period

【試用期間 / Probation Period


No probation period in principle

【給与 / Salary




①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise


Once a year

【賞与 / Bonus


Twice a year (July, December)

【諸手当 / Allowance

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours

8:45~17:45(月~木)、8:4516:00(金)、企画業務型 裁量労働制



Discretionary Work System

【休日 / Holidays


Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."