摘要
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 [email protected] 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? http://www.novartis.com/about/strategy/people-and-culture
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Business Unit
Innovative Medicines
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
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