About the Role

　　生物統計＆CDM Re-examination managementでは, GPSP省令に則った再審査関連業務の管理, 及び発展に関わる業務を担っています。臨床試験ではAuditに該当する自己点検業務や, 再審査関連情報を集約するKnowledge siteの運営, 業界活動への参加と社内へのフィードバック等, プロジェクトに特化しない業務で, その内容は多岐に渡ります。また, 部内のメンバーだけでなく, 製造販売後調査, 製造販売後臨床試験に関わるLine functionと連携して業務を進めることも多くあります。

　　市販後の業務に興味がある方, プロジェクトに特化せず横串をさす業務に興味がある方は, 是非ご応募ください。

　　Job Purpose:

　　Re-examination Manager is responsible for following items;

　　• Provide expertise about post launch activities to CD&A/GDD colleagues by leveraging

　　medical/scientific knowledge through seamless discussion from development phase to

　　the post-launch phase.

　　• Manage and conduct GPSP/Re-examination activities including GPSP agreement with

　　MAH, PSPEC secretary, GPSP training, self-check of CRO related GPSP activities,

　　document management in accordance with GPSP-SOP.

　　Major Activities

　　1) Monitor regulatory changes and industry trends about GPSP/Re-examination system.

　　2) Provide knowledge of epidemiology and post approval activities including regulatory

　　changes and trends to CD&A and GDD-J.

　　3) Monitor regulatory changes and trends and enhance innovative approach (e.g. database

　　study using medical database and registry database) in post launch area to maximize

　　data utilization and lead the industry.

　　4) Lead/Update GPSP/Re-examination related process.

　　5) Prepare and handle with GPSP inspection in GPSP agreement with MAH, self-inspection

　　of CRO and document administration.

　　6) Support operational support for PMS Director.

　　7) Act as PSPEC secretary and support applicant appropriately.

　　8) Develop and update training materials for pharmacovigilance effectively.

　　9) Oversee archiving of GPSP related documents according to internal and external

　　guidelines.

　　10) Contributes to initiatives (e.g., process improvement, training, SOP development, and

　　other line function initiatives).

　　11) Comply with PMD Act（Pharmaceutical and Medical Device Act）/GPSP, SOPs and

　　other related procedures including performing all provided training.

　　12) Ensure adequate reporting of adverse events/technical complaints/compliance issues in

　　accordance with company procedures.

　　13) Lead or serve on Japan process improvement work streams, act as Subject Matter

　　Expert for SOP or trainings, and/or contribute to cross-functional initiatives.

　　14) 100% timely delivery of all training requirements including compliance.

　　Why consider Novartis?

　　817million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

　　We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

　　We are Novartis. Join us and help us reimagine medicine.

　　ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。

　　約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。

　　ノバルティスファーマ株式会社は、スイス• バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

　　Japan

　　Novartis is committed to working with and providing reasonable accommodation to

　　individuals with disabilities. If, because of a medical condition or disability, you need a

　　reasonable accommodation for any part of the recruitment process, or in order to

　　perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact

　　information. Please include the job requisition number in your message.

　　ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束しま

　　す。

　　健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の

　　必須事項を果たすために合理的配慮が必要な場合は [email protected]

　　宛てに電子メール

　　をお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してくださ

　　い。

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　Education:

　　Bachelor degree or advanced degree in life

　　sciences/healthcare required.

　　Experience/Professional requirement:

　　• ≥ 3 years of contribution and accomplishment in all aspects of conducting clinical trials or PMS (e.g., planning, executing, reporting and publishing) in pharmaceutical industry.

　　• DB study planning experience (If possible)

　　• Demonstrated leadership and team management skills.

　　• Considerable organizational awareness including significant experience working cross-functionally and in CDD & Re-exam.

　　• Excellent communication skills, written and oral.

　　• Strong interpersonal skills.

　　• Excellent negotiation and conflict resolution skills.

　　English skill:

　　Capable oral and written English.

　　Division

　　Development

　　Business Unit

　　CD&A GDD

　　Location

　　Japan

　　Site

　　Tokyo

　　Company / Legal Entity

　　Novartis Pharma K.K.

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No