Novartis
Global Program Safety Team Lead(m/w/x)
Vollzeit
Senior
Keine Angabe
Basel
NO
Novartis12 Tage
Global Program Safety Lead(m/w/x)
Vollzeit
Senior
Keine Angabe
Basel
Nejo KI-Zusammenfassung
As a Global Program Safety Lead, you will play a crucial role in ensuring patient safety by providing expert input on clinical development programs, managing safety strategies, and collaborating with various teams to address safety inquiries and issues.
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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
- •Experience with safety issue management
- •Experience in leading cross-functional, multicultural teams
- •Fluent English (both spoken and written)
- •Additional languages are an advantage
- •Clinical Research, Clinical Trials, Functional Teams, Leadership, Medical Strategy, Process Safety Management, Regulatory Compliance, Risk Management, Safety Science
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 from GPT formation through Life Cycle Management
- •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, monitoring, evaluation, and interpretation of safety information
- •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 across the Medical Safety Function
Sprachen
Englisch – verhandlungssicher
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