Band
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: Basel, Switzerland
Work Model: Hybrid
Note: We are currently recruiting for various Therapeutic Areas, and your application will be considered for all relevant positions.
Relocation Support: Novartis is unable to offer relocation support, please only apply if this location is accessible for you.
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
- Medical degree (MBBS or MD) with specialization preferred
- Experience managing clinical safety issues
Languages
- Fluent English (both spoken and written) is mandatory.
- Additional languages are an advantage.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science
