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Global Program Safety Lead(m/w/x)
Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Anforderungen
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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Global Program Safety Lead(m/w/x)
Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Anforderungen
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Über das Unternehmen
Novartis
Branche
Pharmaceuticals
Beschreibung
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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