Novartis
Global Program Safety Lead(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Basel
NO
Novartis2 Tage
Global Program Safety Lead(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will play a crucial part in ensuring patient safety by leading safety strategies and managing safety information throughout the clinical development process. Your day-to-day responsibilities will involve collaborating with teams, overseeing safety evaluations, and responding to regulatory inquiries.
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Anforderungen
- •Medical Degree or equivalent
- •3 years clinical experience postdoctoral
- •Minimum 5 years experience in drug development in a major pharmaceutical company
- •2 years in safety at an operational or medical position
- •Experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
- •Expertise in preparing clinical safety assessments and regulatory reports/submissions
- •Experience with safety issue management
- •Experience in leading cross-functional, multicultural teams
- •Fluent English (both spoken and written)
- •Additional languages are an advantage
Master-Abschluss
ODER
Doktor / Ph.D.
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Provide expert safety input for clinical development programs
- •Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
- •Lead the Safety Management Team
- •Manage safety issues throughout the project lifecycle
- •Own the safety strategy for projects and products
- •Produce medical safety deliverables
- •Develop and maintain safety information in the Core Data Sheet
- •Address safety issues across all project and product indications
- •Oversee signal detection and monitoring of safety information
- •Evaluate and interpret safety data from relevant sources
- •Prepare safety strategies for health authority responses
- •Collaborate with project team members on safety inquiries
- •Respond to regulatory authorities and healthcare professionals regarding safety issues
- •Contribute to departmental and functional goals and objectives
- •Engage in developing competencies within the Medical Safety Function
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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