382128BR
Feb 22, 2024
Spain

About the Role

Location: Barcelona or Madrid, Spain (Hybrid)
Alternate location: United Kingdom (Remote)

About the role:
The GPSL ensures optimal patient safety and leads the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management. This position reports to the Head Patient Safety Immunology.

Key Responsibilities:
• 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

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Essential requirements:
• Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree is required
• Sufficient clinical experience postdoctoral
• Extensive experience of drug development in a major pharmaceutical company within a global role
• Experience 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

Closing date for applications: 12 December 2023

We will be reviewing applications after the closing date and will update you soon afterwards.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Development
Patient Safety & Pharmacovigilance
Spain
Barcelona Gran Vía
United Kingdom
Research & Development
Full Time
Regular
No
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382128BR

Global Program Safety Lead - Immunology

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