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Associate, Safety Case Management

Employer
Novartis
Location
Tokyo, Japan
Salary
Competitive
Closing date
Apr 6, 2023

View more

Discipline
Other
Position Type
Full Time
Organization Type
Pharma

Job Details

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Job Purpose:
Responsible for safety case processing operation at Japan in compliance with Novartis global/local procedures, national and inter-national regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products with quality.

ノバルティスファーマが開発,市販する全ての製品に対し,ファーマコビジランスに関する国内外の規制/基準/ガイドラインに沿って,日本における安全性症例処理業務の責任を負う業務となります.
国内外症例合わせて約11万件/年の症例評価を実施していますが,多くの症例を遅滞なく評価•PMDA報告するため,適切に管理,各プロセスのSMEを設置し対応しています.Safety Case Managementは,有害事象等の症例を収集•評価•検討し安全対策に繋げるための根幹の業務を担っており,質の高い安全性データの収集し,日々日々確実に対応していくことで,患者さんの安全を確保することに貢献しています.

Major Accountabilities:
1. Act as safety case processing SME.
2. Manage safety case processing related procedures, such as MAP and manuals.
3. Train and instruct Case Processors including vendors due to appropriate case processing.
4. Implement case processing procedures that meet local and global HA regulations.
5. Ensure good quality of safety cases.
6. Contribution for conducting and trouble shooting regarding the Case processing including AE reconciliation in compliance with local and global procedures.
7. As a Safety Case Management member of Pharmacovigilance projects in collaboration with other CMO&PS functions to develop business solutions and meet regulatory requirements.
8. Contribute Pharmacovigilance projects in collaboration with other CMO&PS functions to develop business solutions and meet regulatory requirements.
9. 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

Diversity & Inclusion / EEO

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

Minimum Requirements

Education:
Pharmacist or life science with master’s degree

Ideal Background (Desirable)
Experience/Professional requirement:
• At least one year safety case processing experience.
• Good mentoring and coaching skills.
• Quality focused behaviour.
• Self-management skills and ability to work independently without close supervision.
• Good negotiation and oral communication skills, and the ability to operate effectively in an international environment
• Good problem solving and technical skills
• Good presentation skills
• Ability to meet tight timelines
• Ability to work independently or as part of a team and without close supervision

English Skill:
• Good in both written and spoken English
• TOEIC >=800

Company

At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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