Summary
Novartis is seeking passionate individuals to join our innovative team. You will work with cutting‑edge technology, collaborate with experts, and drive excellence in patient safety. If you’re eager to advance your career and be part of a forward‑thinking company, we want you on our team!
About The Role
Key Responsibilities
* Safety Input and Team Participation: Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT). Lead the Safety Management Team (SMT). Responsible for managing safety issues from the formation of the GPT through Life Cycle Management.
* Safety Strategy Preparation: Own the projects/products safety strategy and lead the production of medical safety deliverables.
* Core Global Labelling: Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet, addressing safety issues in all project/product indications.
* Signal Detection and Safety Management: Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant sources.
* Regulatory and Professional Inquiries: Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members. Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues.
* Departmental and Functional Goals: Contribute to and often lead the development of departmental and functional/business unit goals and objectives. Proactively engages in the development of competencies across the Medical Safety Function.
Role Requirements
* Medical Degree or equivalent is preferred; PhD, PharmD or equivalent graduate level health care professional degree required.
* 3 years clinical experience post‑doctoral.
* Minimum 5 years’ experience in 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 clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications.
* Expertise in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
* Experience with (safety or others) issue management.
* Experience in leading cross‑functional, multicultural teams.
Languages
* Fluent English (both spoken and written) is mandatory.
* Additional languages are an advantage.
Skills Desired
Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science.
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
Benefits and Rewards
Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB).
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