Manager for Safety Risk Management (m/f/d)
|Division||Global Drug Development|
|Geschäftseinheit||CMO & PATIENT SAFETY GDD|
|Standort||Holzkirchen (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
1 Billion! That is the number of patients treated with a Novartis product every year. In Patient Safety, our mission is to improve patients’ lives through maximizing the benefit-risk profile of our products.
The purpose of the Manager Safety Risk Management role is to be responsible for all Risk Management and Risk Minimization activities for Novartis Generics, including Risk Management Plans (RMPs), Medical Risk Assessments (MRAs) for Product Quality Investigations, and Signal Detection & Evaluations for assigned products.
Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives? Join Sandoz!
A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
• Define risk minimization strategy for assigned products, ensuring highest possible benefit-risk margin for patients.
• Preparation of RMPs and/or MRAs according to legal requirements and internal procedures.
• Medical Review of RMPs and/or MRAs prepared by colleagues or external Service Providers.
• Handling of Assessment Reports and Health Authority feedback; questions and preparation of answers to Health Authorities.
• Preparation and review of working instructions.
• Proofreading of RMPs and MRAs prepared by external service providers, preparation of feedbacks and quality metrics.
• Presents safety issues to the Safety Management Board.
• Evaluation of Signals and Issues, and deciding on required next steps.
What you’ll bring to the role:
• Highly developed organisational skills and sound organizational understanding and ability to work with a diverse workforce, handling multiple tasks in parallel
• Strong verbal and written communication skills
• Fluent in English
• Proven ability to communicate and collaborate effectively across a global organization
• Adaptability and ability to work under pressure and to tight timelines
• Work experience in a multinational company is a plus
• Higher education, such as Health-Care Professional; desirable: Physician with PhD (Dr. med.; MD, PhD)
• 4 years PV experience
• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits
Why consider Novartis Group of Companies?
750 million. That’s how many lives our products touched in 2018. 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 Sandoz, a Novartis Division. Join us and help reimagine medicine.
We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
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