Medical Safety Lead - Neuroscience
About this role
Summary
You will have a profound impact as a Medical Safety Lead. You'll spearhead safety evaluations, collaborate with dynamic global teams, and craft regulatory strategies that not only protect patients but also drive groundbreaking medical innovations.
About the Role
#LI-Hybrid
Novartis is unable to offer relocation support; please only apply if the location is accessible for you.
Key Responsibilities
- Monitor clinical safety data, literature, and case reports to identify potential safety signals
- Collaborate with cross-functional teams on clinical safety deliverables and study documentation
- 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
- Offer expert evaluation on adverse event reports and guide pharmacovigilance operations
- Conduct medical assessments for individual cases, including follow-ups and quality defect evaluations
Minimum Requirements:
- Bachelor of Science in Pharmacy, Nursing, PharmD, or PhD in a relevant field
- Fluent in spoken and written English; additional language skills are a plus
- Minimum 5 years of experience in drug development, including 2 years in medical safety
- Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally
- Experience contributing to clinical safety assessments and regulatory safety reports
- Strong interpersonal and collaboration skills, with the ability to work effectively across cross-functional and multicultural teams
Desirable:
- Medical Degree (MBBS or MD) or PhD or equivalent would be an advantage.
- Specialization in Neuroscience is preferred. Relevant experience (e.g., clinical, postdoctoral) after graduation.
- Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publication.
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports involving safety information
- Experience with (safety or others) issue management.
- Strong knowledge of clinical trial methodology, regulatory requirements, and scientific analysis
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally
- Experience contributing to clinical safety assessments and regulatory safety reports
- Strong interpersonal and collaboration skills, with the ability to work effectively across cross-functional and multicultural teams
Skills:
- Clinical Trials.
- Functional Teams.
- Literature Review.
- Management Skills.
- Medical Information.
- Medical Records.
- Medical Strategy.
- Pharmacovigilance.
- Regulatory Compliance.
- Risk Management.
- Safety Science.
Accessibility and Inclusion
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.
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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.