345471BR
May 18, 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.

Job Purpose:
Responsible for leading the following activities to ensure compliance with Novartis global/local procedures and pharmacovigilance (PV) national and international regulations/standards/guidelines related to Novartis marketed products and investigational products with quality:
- Monitor compliance and quality metrics of PV activities in PV Japan including vendors.
- Establish and maintain PV processes
- Management of vendors
- Lead and management of root cause analysis (RCA) and corrective and preventive action (CAPA) preparation

Major Accountabilities:
1. Monitor and analyse compliance and quality metrics for PV activities in PV Japan including vendors and escalate identified risks to the stakeholders
2. Lead investigation of deficiencies identified though metrics data analysis and inspection/audits etc., develop and implement CAPA in collaboration with relevant line functions and Quality Assurance.
3. Evaluate the impact of changes to local regulations and global procedures and distribute the information to stakeholders to ensure compliance.
4. Develop and maintain processes of PV activities in PV Japan to meet local and global regulatory requirements by alignment of relevant stakeholders locally and globally
5. 100% timely delivery of all training requirements including compliance.
6. Manage contracted PV services outsourced to ESP/ Partners in accordance with Novartis standards and/or policies and the given regulatory requirements
7. Play a leading role as required for regulatory authority inspections and audits.
8. Play a leading role in the tasks/projects related pharmacovigilance activities

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

Experience/Professional requirement:
• At least one year experience in PV.
• Good mentoring and coaching skills.
• Quality focused behaviour.
• Good communication skills with various stakeholders
• Good problem solving and technical skills.
• Good presentation skills.
• Self-management skills and ability to work independently without close supervision.

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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345471BR

Associate, PV Compliance &Process

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