About the Role

　　全てのノバルティスファーマ製品の安全性リスクマネジメントを担います。開発段階から市販後まで、多種多様な情報源から収集した安全性情報を包括的に評価し、シグナルマネジメント、メディカルインパクト分析等を行い、安全対策を立案• 実行していくとともに、患者さんや医療関係者に対し適切なリスクコミュニケーションを行っていきます。開発プロジェクトでは治験の実施、承認取得に向けて、安全性担当として参画していただきます。

　　Major Accountabilities:

　　1. Accountable for results of personal output or, for non-direct roles, small team targets, or a narrowly

　　defined project or business activity within one location. May have some limited resource

　　accountability.

　　2. Requires awareness of impact of interaction with fellow team members and other contacts.

　　3. Develop, update, and implement local procedures to ensure compliance with Patient Safety

　　global procedures and national requirements.

　　4. Manage the process for collection, processing, reporting and follow-up of all adverse event reports

　　for all Novartis products from Clinical Trials, Non-interventional Studies, Literature, Spontaneous

　　Reports, and any other source of information except for Patient Oriented Program

　　(POPs) and DEAs, SM/SML.

　　5. Develop and update training materials for vigilance and ensure training of Country Organization

　　associates on relevant Patient Safety procedures for AE reporting, including field force and thirdparty

　　contractors, as applicable.

　　6. Manage the process for reporting/submission of safety reports/updates/information (e.g., SAE,

　　SR, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other

　　Country Organization Departments.

　　7. Monitor and analyse compliance and quality metrics for PV activities.

　　8. Ensure quality of prepared and submitted KPI reports on AE reporting or AE follow-up including

　　identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt,

　　development, and implementation of corrective and preventative action(s).

　　9. Ensure support to the internal audits, LHA inspections and implementation of the respective

　　CAPA plan.

　　10. Lead and manage root cause analysis (RCA) and corrective and preventive action (CAPA)

　　preparation for Minor QIs/ observations.

　　11. Support the onboarding of new PS associates and mentor less experienced Patient Safety associates

　　under close collaboration with the PSGM, and maintain role model Novartis values and

　　behaviors.

　　12. Provides specific instruction in own area and recommends improvements to well established and

　　clearly defined processes.

　　13. Encounters problems that are varied but similar. Requires some fact-finding to define problem

　　to identify the most appropriate option or to adapt or improve existing approaches.

　　14. Other agreed tasks assigned by manager.

　　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:

　　Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), Life science

　　degree or equivalent training and experience.

　　Languages:

　　• Fluent in both written and spoken English

　　• Fluent in both written and spoken local language

　　Experience/Professional Requirement:

　　• Knowledge of national and international regulations for pharmacovigilance

　　• Knowledge of pharmacological and medical terminology

　　• Good communication and interpersonal skills

　　• Quality and results oriented

　　• Project management skills

　　• Computer skills

　　• 2 years as Patient Safety Specialist (preferred)

　　• Completion of Investigation Certification Program (preferred)

　　Division

　　Development

　　Business Unit

　　Patient Safety & Pharmacovigilance

　　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