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von: Innovative Medicines
Summary
Verantwortlich für das Arzneimittelüberwachungsprogramm einschließlich der notwendigen Nachverfolgung, Risikobewertung und Produktverwandtwerden zu Berichten über Nebenwirkungen, Aufsicht über die Sicherheit in klinischen Studien und Post-Marketing-Programmen. Beteiligt sich an der Lösung jeglicher rechtlicher Haftung und der Einhaltung behördlicher Vorschriften. Bietet und trägt zur Trend- und Sicherheitssignalerkennung und Risikomanagementbewertung für den Lebenszyklus der Produkte bei. Bietet Sicherheitsunterstützung für die klinischen Entwicklungsteams.
About the Role
#LI-Hybrid
Location: Basel, Switzerland
Working Model: Hybrid
Relocation Support: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support: please only apply if accessible.
Key Responsibilities
- Lead scientific projects and evaluations of safety topics across early development, full development, and marketed products
- Guide mechanistic investigations and integrate safety insights into cross-functional development activities
- Co-lead Safety Science platform meetings such as the Early Safety Hub (ESH) and Early Portfolio Safety Group (EPSG)
- Support preparation and scientific quality of safety board meetings, including Integrated Safety Assessment Board (ISAB) and Medical Safety Review Board (MSRB)
- Review and advise on mechanistic studies, Risk Management Plans, and safety signal action plans
- Contribute to safety training and knowledge sharing within Patient Safety as well as important clinical partner functions (Clinical Development, Translational Medicine and Translational Clinical Oncology)
- Collaborate with internal and external experts to advance safety science standards and practices
Essential Requirements
- Medical degree (preferred) or PhD with relevant drug safety experience in a pharmaceutical or biotech company
- Peer-reviewed publications in pharmacology, clinical research or safety
- 3–5 years of postdoctoral or clinical experience
- 3–5 years of drug development experience in academia or the pharmaceutical industry
- Proven experience preparing clinical safety assessments and regulatory safety submissions
- Strong leadership in cross-functional, multicultural team environments
- Deep understanding of clinical trial methodology, regulatory standards, and scientific writing
- Fluent in English, both spoken and written
Desirable Skills
- Understanding of an additional major language (e.g. French or German)
- Experience contributing to external scientific collaborations in drug safety
Ready to shape the future of safety? Apply now and bring your scientific leadership to a team that’s transforming lives.
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 inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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?
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