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Job Description Summary
Join our dynamic Cardio Renal Metabolic (CRM) team at Novartis, where we are committed to enhancing patient safety and improving healthcare outcomes.We are looking for a passionate and experienced Global Program Safety Lead to lead our drug surveillance program and ensure compliance with governmental regulations.
Job Description
Primary Location: Barcelona, Spain
Alternate Location(s): London, United Kingdom
Working model: All locations have a hybrid working model (which requires 12 days per month in the office)
Note: Novartis is not able to offer relocation support for this role. Please only apply if the location is accessible for you.
Major accountabilities:
- Design and develop safety surveillance strategies for our products.
- Oversee the company's drug surveillance program, including follow-up, risk assessment, and relatedness to product on adverse reaction reports.
- Provide safety support to clinical development teams and participate in the resolution of any legal liability.
- Manage safety issue resolution from the formation of the Global Program Team (GPT) through Life Cycle Management.
- Develop and maintain key internal safety documents and ensure they are regularly updated.
- Lead the preparation of safety strategies for health authority responses and collaborate with project team members.
- Contribute to the development of departmental and functional/business unit goals and objectives.
- Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
Role Requirements:
- Medical Degree or equivalent (preferred), PhD, PharmD or equivalent graduate level health care professional degree required
- 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
- Significant experience with (safety or others) issue management
- Proven expertise in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
- Solid experience in leading cross-functional, multi- cultural teams
Languages :
- Fluent English - both spoken and written is essential
- Understanding in another major language (e.g. French, German, Spanish) is desirable
Skills Desired
Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team ManagementNovartis London, England Office
The WestWorks, White City Place, London, United Kingdom, W12 7FQ
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