CatalYm
Senior Safety Physician(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BABavarian Nordic GmbH
Head of Medical Safety GCSP(m/w/x)
Martinsried
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading a team of six physicians and scientists for clinical safety contributions and life-cycle management of marketed vaccines. Medical Doctor degree and leadership experience in clinical safety and pharmacovigilance required. Serving on GCSP Leadership Team and assigned governance committees.
Anforderungen
- Medical Doctor (MD) degree
- Leadership experience in clinical safety and pharmacovigilance
- Setting direction
- Taking accountability
- Leading teams with passion, clarity and empathy
- Strategic oversight
- Confident decision-making
- Strong ethical stakeholder engagement
- 10+ years experience in clinical safety and pharmacovigilance
- Senior Medical Safety roles
- Deep regulatory expertise in global safety activities
- Signal management
- Risk minimization
- Solid knowledge of global clinical safety and pharmacovigilance regulations
- GCP knowledge
- GVP knowledge
- ICH guidelines knowledge
- Hands-on experience in CTD compilation
- MAAs/BLAs submissions experience
- Fluent English communication
- Solid written, verbal, and presentation skills
- Proficiency in relevant IT tools and database applications
- Self-driven
- Positive team player
- Ability to build and sustain high performance and team cohesion
- Thrive in change
- Judgment
- Integrity
- Resilience
- Safeguard patient safety
- Support transition from development to commercialization
- Advanced degree
- MD qualification mandatory
Aufgaben
- Lead and develop a team of six (Sr) Safety Physicians and (Sr) Safety Scientists
- Ensure high-quality clinical safety contributions to development programs
- Manage life-cycle safety for marketed products in compliance with regulations
- Serve on the GCSP Leadership Team and assigned governance committees
- Support GCP and GVP audits and inspections
- Contribute to company strategic initiatives and innovations
- Stay updated on innovative technologies and regulations in your field
- Mentor team members and foster their professional growth
- Collaborate with global stakeholders on safety processes
- Contribute to regulatory submissions and patient safety
- Shape and execute safety processes and risk management activities
- Maintain and develop appropriate tools and skillsets for the team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- CTD compilation
- MAAs/BLAs submissions
- IT tools
- database applications
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bavarian Nordic GmbH 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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BABavarian Nordic GmbH
Head of Medical Safety GCSP(m/w/x)
Martinsried
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Leading a team of six physicians and scientists for clinical safety contributions and life-cycle management of marketed vaccines. Medical Doctor degree and leadership experience in clinical safety and pharmacovigilance required. Serving on GCSP Leadership Team and assigned governance committees.
Anforderungen
- Medical Doctor (MD) degree
- Leadership experience in clinical safety and pharmacovigilance
- Setting direction
- Taking accountability
- Leading teams with passion, clarity and empathy
- Strategic oversight
- Confident decision-making
- Strong ethical stakeholder engagement
- 10+ years experience in clinical safety and pharmacovigilance
- Senior Medical Safety roles
- Deep regulatory expertise in global safety activities
- Signal management
- Risk minimization
- Solid knowledge of global clinical safety and pharmacovigilance regulations
- GCP knowledge
- GVP knowledge
- ICH guidelines knowledge
- Hands-on experience in CTD compilation
- MAAs/BLAs submissions experience
- Fluent English communication
- Solid written, verbal, and presentation skills
- Proficiency in relevant IT tools and database applications
- Self-driven
- Positive team player
- Ability to build and sustain high performance and team cohesion
- Thrive in change
- Judgment
- Integrity
- Resilience
- Safeguard patient safety
- Support transition from development to commercialization
- Advanced degree
- MD qualification mandatory
Aufgaben
- Lead and develop a team of six (Sr) Safety Physicians and (Sr) Safety Scientists
- Ensure high-quality clinical safety contributions to development programs
- Manage life-cycle safety for marketed products in compliance with regulations
- Serve on the GCSP Leadership Team and assigned governance committees
- Support GCP and GVP audits and inspections
- Contribute to company strategic initiatives and innovations
- Stay updated on innovative technologies and regulations in your field
- Mentor team members and foster their professional growth
- Collaborate with global stakeholders on safety processes
- Contribute to regulatory submissions and patient safety
- Shape and execute safety processes and risk management activities
- Maintain and develop appropriate tools and skillsets for the team
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- CTD compilation
- MAAs/BLAs submissions
- IT tools
- database applications
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bavarian Nordic GmbH 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Bavarian Nordic GmbH
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
Noch nicht perfekt?
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