Medical Safety Lead - Neuroscience

#LI-Hybrid

Location: Basel, Switzerland

Work Model: Hybrid working model

Relocation Support:   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 E-Mail schreiben 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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