Job Description Summary
Join Novartis and make a profound impact on patient safety!
As a Medical Safety Lead youll 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
Job Description SummaryJoin Novartis and make a profound impact on patient safety! As a Medical Safety Lead youll 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 ...
Job Description Summary
Join Novartis and make a profound impact on patient safety!
As a Medical Safety Lead youll 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
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