347883BR
Aug 08, 2022
Japan

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.

多様な製品について,開発から市販後フェーズで収集する文献情報及び集積した症例情報の評価及びレポーティングに携わっていただきます。多くのレポートを規制上の報告期限内に効果的に行うためのオペレーショナルエクセレンスとともに,文献や集積した安全性情報を適切に評価し,科学的にも高品質な成果物を創出できる組織を目指します。

Job Purpose:
Evaluate and execute literature and aggregate report as pharmacovigilance activities for all
assigned Novartis projects or products in order to manage safety risks, collaborating with
Japan Medical Safety.

Major Accountabilities:
1. Evaluate safety literatures and aggregate cases and prepare for reports to
submit PMDA.
2. Answer to inquiries about aggregate, research and foreign safety measure
reports from PMDA, etc.
3. Play an active role as required for regulatory authority inspections and audits.
4. Play an active role in the trouble shooting regarding the reporting and
literature review in compliance with local and global procedures.
5. Play an active role in cross-functional teams activities relating safety matters
6. Conduct training and provide mentoring of Patient Safety junior Associates
and contract staffs.
7. Execute tasks with ICU culture and affect to junior associates.
8. Support to manage contract staffs and vendors with Head and manager for
appropriate collection and evaluation of safety information
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
Role Profile Head, Japan Product Safety Page 2 of 2

Experience/Professional requirement:
At least one year experience in drug safety / Development or closely related areas of responsibility
Good mentoring and coaching skills
Good organizational, planning and project management skills
Good problem solving
Good presentation skills
Good understanding and enough knowledge for physiology, pharmacology, epidemiology, related regulation etc.
Ability to lead and deliver initiatives
Ability to work independently or as part of a team and without close supervision
Ability to work under pressure and meet tight timelines
English Skill:  Good in both written and spoken English
TOEIC >=800
Global Drug Development
CMO & PATIENT SAFETY GDD
Japan
Tokyo
Research & Development
Full Time
Regular
No
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347883BR

Associate, Literature & Aggregate Report

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