Novartis
Global Program Safety Team Lead(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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NONovartis
Global Program Safety Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing drug safety strategy and managing issues for clinical development programs from early stages through life cycle management at a major pharmaceutical company. Medical Degree, 5 years in drug development, and 2 years in safety required. Global program scope, working with cross-functional teams.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
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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NONovartis
Global Program Safety Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Overseeing drug safety strategy and managing issues for clinical development programs from early stages through life cycle management at a major pharmaceutical company. Medical Degree, 5 years in drug development, and 2 years in safety required. Global program scope, working with cross-functional teams.
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
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
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.
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.
Noch nicht perfekt?
- Novartis
Global Program Safety Team Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis Pharma AG
Global Head Mechanistic Safety and Safety Signal Management(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Senior Vice President - Global Head of Safety Risk Management(m/w/x)
Vollzeitnur vor OrtManagementBasel - Roche
Associate Safety Director(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil