338358BR
Feb 11, 2022
USA

Job Description

*Roles will be filled at level commensurate with experience and in the following locations: United States, Europe (Switzerland, Spain) and United Kingdom. Successful candidate(s) will be hired in local area of application*

Therapeutic Areas include, but are not limited to: Immunology, Hepatology and Dermatology; Neuroscience; Ophthalmology; Oncology; BioPharma & Generics

Job Description :
766 million. That’s how many lives our products touch. 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?

You will ensure optimal patient safety and will be responsible for the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management.

Your responsibilities include, but are not limited to:

• Providing expert safety input to the clinical development program for assigned projects/products, participating as an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Developing, and overall responsibility for key internal Novartis safety documents: reviewing these documents regularly and updating as required (e.g. when significant new information is received). Ensuring that these, and all other project-related safety documents (e.g. DSUR, PSUR, RMP), are consistent in safety messages
• 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. To this end, constituting and running the Safety Management Team (SMT); ensuring that this team reviews all medical safety data from various sources (e.g. pre-clinical, clinical trial data post-marketing, literature) throughout the development and post-approval process in an appropriate and timely manner
• 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 submissions, responses and strategy, in collaboration with other project team members

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

Job Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are currently recruiting for multiple available roles, as well as building a pipeline for future opportunities. If you would like to be considered, then please submit your CV.

Minimum Requirements

What you will bring to the role:

• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree is required

Global Program Safety Lead:
• +3 years clinical experience postdoctoral and +5 years’ experience of drug development in a major pharmaceutical company (of which 2 years should be in a global position)
• +2 years in safety at an operational or medical position, with experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management
• Experience with designing safety strategy required
• Experience in leading cross-functional, multi-cultural teams and of (safety or other) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications

Sr Global Program Safety Lead:
• 5 years clinical experience postdoctoral
• At least 7 years progressive experience in drug
development in a major pharmaceutical company (of
which 5 years in a global position), including 5 years in
safety at a medical position
• Expertise in preparing or contributing to preparation of
clinical safety assessments and regulatory reports/submissions involving safety information – to
include NDA submission documents
• Strong experience in leading cross-functional, multicultural teams
• Experience with (safety or others) issue
management
• Experience in drug development, clinical trial
methodology, regulatory requirements, scientific
methodology, statistics and writing of publications
• Leadership skills including coaching, motivating,
and directing, and fostering teamwork

Why consider Novartis?
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

Accessibility and reasonable accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…
Global Drug Development
CMO & PATIENT SAFETY GDD
USA
East Hanover, NJ
Switzerland
Spain
United Kingdom
Research & Development
Full Time
Regular
No
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338358BR

Global Program Safety Lead/Sr (Multiple Locations & Therapeutic Areas)

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