Associate, Safety Case Management

Closing date
Apr 8, 2023

View more

Pharmaceutical, Pharmacovigilance
Full Time
Organization Type
Jobseeker Type
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.

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.


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

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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert