Manager Safety Risk Management (d/f/m)
- Holzkirchen, Germany
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 Corporate Safety Physician 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.
Your responsibilities include, but not limited to:
• Define risk minimization strategy, ensuring the 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 organizational skills and sound organizational understanding and ability to work with a diverse workforce, handling multiple tasks in parallel
• Good verbal and written communication skills
• Proficiency 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 Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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