Medical Safety Lead
NovartisBand
Level 5
Job Description Summary
Join Novartis and make a profound impact on patient safety!
As a Medical Safety Lead, 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!
Job Description
#LI-Hybrid
Primary Location: London (White City), UK
Work Model: Hybrid
Relocation Support: Novartis is unable to offer relocation support; please only apply if this location is accessible for you.
About the role:
Key Responsibilities
- 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
Essential 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 Requirements
- Medical degree (MBBS or MD) with specialization preferred
- Experience managing clinical safety issues
Skills Desired
Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science