Global Program Safety Lead, Hematology (80-100%*) " >Global Program Safety Lead, Hematology (80-100%*)

Nov 10, 2021

Job Description

769 million. That’s how many lives our products touched in 2020. 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?

As Global Program Safety Lead, your responsibilities 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)
• Responsibility for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management
• Developing 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
• Responsibility for documentation/tracking/record keeping of the assigned compounds medical safety activities
• Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues effectively in all project/product labeling indications
• Responding 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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required. Specialty Board certification desirable.
Useful additional degrees: Post graduate degree in
Pharmaceutical Medicine; Master of Public Health in
Epidemiology (or equivalent)
• 3 years clinical experience postdoctoral
• 5 years drug development experience in a major pharmaceutical company (of which 2 years should be in a global position); including 2 years in safety at an operational or medical position
• Experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management
• Prior experience of leading cross-functional, multi-cultural teams
• Experience in leading cross-functional, multi-cultural teams and of (safety or others) issue management

*Some restrictions on flexible working may apply and will be discussed at interview if applicable

**Some restrictions to flexible working models may apply and will be discussed at interview if applicable

Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here 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:
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Global Drug Development
Research & Development
Full Time
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Global Program Safety Lead, Hematology (80-100%*)

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