334373BR
May 09, 2022
Japan

Job Description

安全性では、開発段階から市販後まで全てのノバルティスファーマの製品に対するファーマコビジランス活動を担っています。
全ての情報源から収集した安全性情報を包括的評価に基づく安全性シグナルの特定、解析、適切な情報提供、並びに安全性リスクの管理業務を行っています。
ご興味のある方は是非ご応募ください!

1. Play an active/leading role in cross-functional teams on safety matters/Patient Safety special projects relating to investigational and marketed drugs.
2. Coordinate and/or conduct training and provide mentoring of Patient Safety Associates and other line functions/business units and vendors (e.g. Clinical Development, RA, Sales, Medical, GCO, etc).
3. Work closely with the Head Japan Product Safety to allocate and monitor resource requirements including: coordinating activities involving the CO Patient Safety team, other line units, and/or contractors utilized to augment the regular Patient Safety staff. Activities may be related (but not limited) to administrative functions, training of other team members, or leading targeted drug-specific data collection efforts.
4. Answer product related safety inquiries *(using approved information from the Japan Package Insert) to better educate HCP and enable them to make informed decisions regarding treatment for their patients
5. Coordinate and/or contribute to all required Japan regulatory periodic reports, re-examination dossier.
6. Support Global Medical Safety in monitoring the safety profile of product by raising attention to any potential issues or signals. Lead working groups when a safety issue occurs for investigation and assessment of the specific problem(s) and for the proposal and implementation of any action/change recommended and approved without undue delay
7. Provide support as required for, regulatory authority inspections and audits.
8. Update of J-RMP
9. Work with RA/PI to prepare for PVO’s responsible parts of labelling change
10. Draft safety parts of J-CTD dossier including J-RMP
11. Prepare and conduct EPPV
12. Ensure adequate reporting of foreign safety measure report/research report in accordance with company procedures
13. 100% timely delivery of all training requirements including compliance

Diversity & Inclusion / EEO

ノバルティスは、優れた包括的な職場環境と、私たちがサービスを提供する患者さんや地域社会を代表する多様なチームの構築に取り組んでいます。

Minimum Requirements

Education:
• Pharmacist with a master’s degree in a medical branch
or Life science with a master’s degree or Medical Doctor

Experience/Professional requirement:
• At least 2 years’ experience in drug safety / Development or closely related areas of responsibility
• Good mentoring and coaching skills
• Ability to lead and deliver initiatives.
• Thorough understanding of clinical trial methodology, GCP and medical terminology
• Attention to detail and quality focused
• Good organizational, planning and project management skills
• Good negotiation and oral communication skills, and the ability to operate effectively in an international environment
• Thorough understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Good problem solving and technical skills
• Good presentation skills
• 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:
• Fluent in both written and spoken English
• **TOEIC >=800

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
Global Drug Development
CMO & PATIENT SAFETY GDD
Japan
東京
フルタイム
正社員
いいえ
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334373BR

Medical Safety Japan Expert

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