基本情報

求人名 Associate PV Literature Manager

勤務地 Nihonbashi, Tokyo

事業部 ファーマコヴィジランス

雇用形態 正社員

仕事内容

【Purpose & Scope】

ファーマコヴィジランス部は、グローバルで一体となり安全管理情報の収集、評価および報告、集積情報の分析、安全確保措置の検討・立案等の安全管理業務等を遂行しています。多くの海外メンバーと協働して、揺ぎない信頼のもとに私たちの医薬品を使用して頂くことを通し、世界の人々の健康に貢献する非常にやりがいのある部門です。特にLiterature  managementチームは、安全管理情報の重要な情報源の1つである文献を適切に収集、評価するためのポリシーと手順の確立、維持、実装に貢献します。過去や現状にとらわれず、担う責務や環境を楽しみ、自ら進んでチャレンジしていける方を募集しています。


Responsible for PV literature management by ensuring up to date and best practice global processes and procedures including Japan local requirements, and training, as well as continuous improvement of literature management activities globally.

Contributes to develop, maintain, and implement PV literature management policies and procedures. Delivers outputs according to procedures for all activities for PV Literature Management for all PV purposes including but not limited to ICSR, signal detection, risk management, pharmacoepidemiology, and periodic reporting, including both in-house and outsourced activities.

This individual contributor role reports to the PV Literature Management Lead.

Collects and maintains global literature search and review parameters for all PV purposes including Japan specific items, provides key metric information, and leads or participates in continuous improvement initiatives with the in-house and outsourced service providers.

Measures the quality and regulatory compliance of literature management activities delivered under PV Operations as well as the Astellas affiliates by monitoring those activities and facilitates global consistency.

Acts as Subject Matter Expert for regulatory compliance and inspection readiness of (outsourced) PV literature management activities.

Work in close collaboration with PV Case Management, PV SIM, PV COPE, Affiliate Management, Medical Safety Science as well as selected vendor personnel, and ensures that the literature management activities align with PV vision and those outputs directly support the ongoing assurance of the safety profile of Astellas products.



【Essential Job Responsibilities】

下記の主要業務の実施および管理

1)グローバルレベルでの文献検索および評価手順の立案、管理、効率化の提案

2)地域及びグローバルレベルでのベンダー及び社内スタッフへのトレーニング、クエリに対する回答

3)日本の規制を適切に順守するためのグローバルメンバーとのリエゾン

4)文献管理業務に関わるプロセス改善活動やプロジェクトへの参画


The PV Literature associate manager is responsible for:

Literature Management:

• Contribute to development and maintenance of global standards and procedures for literature search and review

• Contribute to oversight and implementation of vendor activities

• Contribute to an effective and collaborative working relationship with aligned literature vendors

• Collaborate with JP literature SME as liaison

• Identify opportunities to increase efficiency and effectiveness in the literature management procedures and propose plans to implement process improvements

Quality Assurance:

• Support development and maintenance of the quality of literature database

• Participate in PV Literature Management Quality Improvement activities

• Act as Subject Matter Expert in audits and inspections

Training:

• Develop and maintain global training materials for PV Literature Management

• Deliver training of Literature Management Process to literature reviewers and other stakeholders

Vendor & Outsourcing Management:

• Support day-to-day management and oversight of the selected PV Literature Management vendor(s) and/or in-house PV literature service provider as applicable



【Specific Physical or Environmental Requirements】

・ファーマコヴィジランスス部勤務(東京)

・社内グローバル会議参加(適宜夜間の開催あり)



【Qualification】

・医薬品を適正に使用頂く活動を通じて世界中の患者さんに貢献したい方

・安全管理情報(有害事象等)や文献の取扱いに興味がある方

・機能横断的なチームやベンダーと良好なコミュニケーションの取れる方


【Required】

・Minimum MS, preferably with an advanced professional degree

・Minimum of 2-6 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development or medical information, including extensive leadership experience, including ability to lead and manage a global, multidisciplinary team.

・Requires significant communication and leadership skills and the ability to create and implement the function’s mission and integrate it with that of the department.

・Experience in quality and process improvement activities and outsourcing and vendor management.

・Problem solving and negotiation skills in complex issues and able to make decisions independently.

・Able to ensure consistency and efficiency as well as monitor and maintain priorities and project progress across regions.

・Knowledge of pharmacovigilance processes, and adverse event reporting and processing and operations.

・Able to lead meetings, present orally and interact with external bodies.

・Communication and presentation skills in English (written and spoken):TOEIC 730点以上


【Preferred】

In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.

Proven experience with establishing and maintaining (GxP) Qualities Management System.

Experience to participant in projects in a heavily matrixed and/or cross-functional environment; demonstrated ability to effectively manage departmental budgets


社外セミナー、研修等に参加頂き、専門性を高めて頂くことも想定しています。ついては、上記の応募要件に達していなくても自ら考えて進んで行動し、上記の要件を達成するように、継続した努力ができる方が望まれます。



【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."