Summary
As our Medical Safety Lead in our Cardio Renal Metabolic team, you'll spearhead safety evaluations, collaborate with dynamic global teams, and craft safety strategies that not only protect patients but also drive groundbreaking medical innovation.
Be a part of something extraordinary!
About the Role
Primary Location: Barcelona (Grand Via), Spain
Working Model: #LI-Hybrid Hybrid (12 days per month on-site)
Alternate Location: London (The Westworks), United Kingdom
Working Model(s) #LI-Hybrid Hybrid (12 days per month on-site if living within 50 miles of our London office)
#LI-Remote Remote (if living beyond 50 miles of our London office)
About the role:
Major accountabilities:
- Monitor clinical safety data, literature, and case reports to identify potential safety signals
- Conduct medical assessments for individual cases, including follow-ups and quality defect evaluations
- Perform signal detection and evaluation using aggregate and single-case data
- Contribute to regulatory responses and prepare safety data for health authority reviews
- Support safety input for core data sheets and related regulatory documentation
- Provide medical input for aggregate safety reports and risk management plans
- Collaborate with cross-functional teams on clinical safety deliverables and study documentation
- Offer expert evaluation on adverse event reports and guide pharmacovigilance operations
Minimum Requirements:
- Master of Science / PharmD / PhD in a relevant field
- Fluent in spoken and written English; additional language skills are a plus
- Minimum 4 years of experience in drug development, including 2 years in patient safety
- Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
- Proven ability to interpret and present safety data clearly and effectively
- Experience contributing to clinical safety assessments and regulatory safety reports
Desirable Skills:
- Medical degree (MBBS or MD) with specialization preferred
- Experience managing clinical safety issues
- Experience in Cardio/Renal/Metabolic therapy area
Ready to make a difference? Apply now and help us reimagine medicine for millions of patients worldwide.
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)
VIDEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
