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
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.
ファーマコヴィジランス部(以下、PV部)は、安全情報の収集、評価および各規制当局への報告、集積データを用いた安全性シグナルの評価、安全確保措置の検討・立案等の安全管理業務等を行っているグローバル組織です。【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
• 日本定期報告類の帳票を含む日本語カスタム帳票のデザイン・開発を管理し、ビジネス要件を満たしていることを確保する
• 日本の帳票開発戦略をリードし、日本語帳票作成に最適なソリューションを見出す
• PV内の製品担当者が安全性データ解析を実施するにあたり、システム・帳票の専門家として最適な解析方法を見出すためのアドバイスを行う
• データおよびレポートガバナンス活動に貢献する
• 日本におけるPVビジネスインテリジェンス活動をリードする
• グローバルチームと連携してグローバル帳票に関する要望に取り組み、またグローバルプロジェクトに参画する
【Qualifications】
• 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
• 個別症例報告や定期報告等の基本的なPV業務についてある程度知識がある方
• 安全性データベース関わる業務経験があり、帳票作成に関わったことがある方
• プロジェクトを管理し、帳票開発を管理できる方
• 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)
• 変革に積極的かつ意欲的に取り組める方
【Required】
• 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
• PV業務に関する知識
• 有害事象個別症例報告および定期報告等に関する規制(PMDAおよびグローバル)に関する知識
• システムバリデーションに関する知識
• ビジネス分析および安全性データシステムの要件定義に関するスキル
• 安全性データベースおよびコンフィグレーションに関する知識
• システム帳票のデザインおよびバリデーションに関する知識
【Preferred】
• Advanced degree (MA and/or PhD or related degree) is preferred.
• SQL programming
• 修士または博士
• 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】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
①基本給:当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給
③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
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】
年一回
Once a year
【賞与 / Bonus】
年2回(7月、12月)
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)、8:45~16:00(金)、企画業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす
8:45~17:45(Mon~Thu)、8:45~16:00(Fri)
Discretionary Work System
【休日 / Holidays】
完全週休2日制、祝日、5月1日、夏季、年末年始
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.
astellas.recruit@jp.astellas.com
※本職種についてのご質問は、上記までお問い合わせください。
"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."