CatalYm
Senior Safety Physician(m/w/x)
Full-time/Part-timeWith HomeofficeSenior
München
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BABavarian Nordic GmbH
Head of Medical Safety GCSP(m/w/x)
Martinsried
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- CTD compilation
- MAAs/BLAs submissions
- IT tools
- database applications
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BABavarian Nordic GmbH
Head of Medical Safety GCSP(m/w/x)
Martinsried
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- CTD compilation
- MAAs/BLAs submissions
- IT tools
- database applications
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Bavarian Nordic GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
Not a perfect match?
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