Safety risk management Manager
Tokyo, Japan Permanent Date posted Oct. 28, 2024■職務内容：
医薬品の安全性に関するリスクを管理し、以下のPV活動を通じて、製品のベネフィット/リスクバランスの最適化に貢献します。
・安全性データの正確かつ迅速な分析に基づく予防的な安全対策の実施
・社内外のステークホルダーとの協働による医薬品リスク管理の実施
・重要な安全性シグナルのタイムリーな検出および評価
・製品の安全性検討事項に基づく、規制当局およびグローバルPVとの緊密なコミュニケーション
・必要なリスク最小化活動の計画と実行をプロアクティブに行う
・臨床開発段階から市販後まで、エビデンスに基づく質の高い安全性分析と評価を一貫して行う
■主な業務内容：
・J-RMP（医薬品リスク管理計画書）の作成、改訂
・リスク最小化策の計画・実施・評価（医療関係者向け資材、患者向け資材、情報提供等）
・EPPVの計画、管理、規制当局への報告
・文献・海外措置情報の評価、規制当局への報告
・安全確保措置の立案（使用上の注意改訂の立案、等）
・安全確保措置実施の計画・管理・報告書作成（情報提供等）
・規制当局とのコミュニケーション(照会事項対応)
■必要なスキル：
・医薬品に関する科学的知識およびデータ分析スキル
・プロジェクトマネジメント/タスク管理スキル
・日本語（必須）、英語（ビジネスレベル）でのコミュニケーション能力
・規制要件を含むファーマコビジランス活動に関する知識
Job summary：
Manage safety risks and contribute to optimizing the benefit / risk balance of our products through the following PV activities
・Execution of proactive safety measures based upon accurate and prompt analyses of safety data
・Implementation of risk management for our products in conjunction with stakeholders
・Detecting and evaluating important safety signals timely
・Close communication with health authority and GPV based upon safety specification of our products
・Planning and execution of necessary risk minimization activities proactively ・Consistent and high-quality safety analysis and evaluation from clinical development phase to post marketing phase
Skills:
・Scientific knowledge about pharmaceuticals and data analysis skills
・Project / task management skills
・Communication skills in Japanese (required for communicating with HA) and English (business level)
・Knowledge of pharmacovigilance activities including regulatory requirements (GVP, GCP)
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
You have not viewed any jobs yet.
You have not saved any jobs yet.
Developing
our talent
We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.
Find out more about this location
Experience possibility
-
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Emmanuel
Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.
-
Dimitrije
Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.
-
Ziv
Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.
-
When you grow, we all grow
We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
-
Bolder, better futures
Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.
-
Our locations
We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Sanofi at Cambridge Crossing
Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Our people & culture
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Sanofi's Postdoctoral Program
Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.
-
Physician Careers at Sanofi
At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.
-
AI Centre of Excellence
The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.
What could we achieve together?
Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.
What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.