Medical Safety Lead - Neuroscience
Medical Safety Lead - Neuroscience
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1 Vacancy
Job Description
Job Description Summary
Join Novartis and be a part of something extraordinary!You will have a profound impact as a Medical Safety Lead. Youll spearhead safety evaluations collaborate with dynamic global teams and craft regulatory strategies that not only protect patients but also drive groundbreaking medical innovations.
Job Description
#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 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.
Skills Desired
Clinical Trials Functional Teams Literature Review Management Skills Medical Information Medical Records Medical Strategy Pharmacovigilance Regulatory Compliance Risk Management Safety ScienceEmployment Type
Full-Time
