Summary
About the Role
Major Accountabilities:
This role offers hybrid working, requiring 3 days per week/ 12 days per month in our White City, London office.
As Global Labelling Compliance Project Lead, you will be responsible for:
The tracking, data mining, monitoring and reporting on the global implementation of safety related product information changes e.g. Core Data Sheet amendments and updates. This includes routine interaction and follow-up with Country (CO) and Regional Regulatory Associates and other cross-functional teams, including Quality Assurance (QA), Process Improvement & Excellence (PIE) and Technical Operations.
Routine compliance reporting for global and local regulatory milestones of the Novartis safety label change process; support root cause analysis for any delays or non-compliance.
Supporting internal Pharmacovigilance (PV) CO audits, interacting with the COs to ensure timely and current safety label change (SLC) compliance data and reports are provided.
Supporting local and global PV inspections through preparation of requested SLC data and reports as required.
Supporting the evolution and maintenance of the Novartis safety label change tracking tool (SALTO) and related projects as a SALTO Super User.
Providing input for process improvements, training manuals and materials, IT labelling projects and user testing.
Supporting development of Novartis systems and company projects.
Your Experience:
Bachelor’s degree required with relevant regulatory and/or technical experience gained in the pharmaceutical industry.
Knowledge of Regulatory Affairs, specifically labelling regulations globally, labelling submission business processes and related tools.
Proven knowledge of data analysis and reporting, excellent verbal and written communication skills, technical/IT skills and proven ability to be innovative and a creative problem solver with quality and compliance approach.
Fluency in English as a business language required.
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
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
