Global Program Safety Lead / Senior Global Program Safety Lead - CRM

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 Management