Senior Global Program Safety Lead, Cardio Renal Metabolic (80 - 100%*)
- Basel, Switzerland
Over 2 Million people! This is how many patients with Heart Failure we have treated! Our Cardio-Renal-Metabolic Development Unit is making courageous choices to develop treatments to transform lives. We are committed to reduce the global burden of Heart Failure, Atherosclerosis, Renal diseases and Metabolic disorders on patients, families, and communities.
As Senior Global Program Safety Lead, you will ensure that we safely offer transformative treatments for Heart Failure patients and lead the safety surveillance strategy for products before and after approval. You will be responsible for the company's drug surveillance program and will maintain the overview of safety in clinical trials and post marketing programs. In addition, you will provide and contribute to trending safety signal detection and risk management assessment for the products' life cycle, providing safety support to the clinical development teams and contributing safety expertise to the development strategy.
Your responsibilities will include but are not limited to:
• Providing expert safety input to the clinical development program for assigned projects/products and being an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Development and responsibility for key internal Novartis safety documents: reviewing these documents regularly and updating as required
• Responsibility for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
• The initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.
• Responsibility for responses to inquiries from regulatory authorities or health care professionals on safety issues
• Leading the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members.
What you'll bring to the role:
• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required.
• Fluent in spoken and written English
• 3 years clinical experience postdoctoral
• At least 5 years experience of drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information
• Prior experience of leading cross-functional, multi-cultural teams
• Experience with (safety or others) issue management, drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
*Some restrictions on flexible working models may apply and will be discussed at interview if relevant
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis 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.
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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