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Medical Safety Lead
hace 2 semanas
**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
**About the Role**:
**2 positions available within our Cardio Renal Metabolism Therapeutic Area**
**Location(s)**: Barcelona, Spain or London, England
**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
**Role 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
Division
Development
Business Unit
Universal Hierarchy Node
Location
Spain
Site
Barcelona Gran Vía
Company / Legal Entity
ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Alternative Location 1
London (The Westworks), United Kingdom
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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