Bavarian Nordic GmbH
Senior Quality Assurance Specialist - GVP(m/w/x)
Full-timeRemoteSenior
Martinsried
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Leading multidisciplinary Benefit Risk Teams for rare disease therapies. MD, PharmD, or PhD with 8+ years clinical/pharma R&D experience required. Extensive cross-functional and partner company interaction.
Requirements
- Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
- 8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
- 5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
- Experience leading cross-functional global product safety management teams
- In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
- Experience working with partner companies in global markets
- Experience presenting medical safety information at Health Authority meetings
- Fluency in written and spoken English
- Strong communication and team-leadership capabilities
- Sound judgment skills and ability to assess and handle risks
- Expertise in resolving or escalating issues as appropriate
Tasks
- Lead the multidisciplinary Benefit Risk Team for product safety
- Drive signal detection, analysis, risk management, and safety labeling
- Provide pharmacovigilance and clinical safety expertise at the product level Medical Development Team
- Contribute to clinical development through design, conduct, data analysis, and interpretation
- Oversee safety science interactions with partner companies
- Develop and implement signal management activities
- Provide medical and pharmacovigilance expertise for clinical safety strategy and regulatory documents
- Lead Safety Science input for post-marketing activities and risk minimization measures
- Support regulatory submissions and product expansion activities
- Respond to medical safety-related inquiries and assist with audits and inspections
- Represent Global Pharmacovigilance in interactions with stakeholders, including Regulatory Authorities and Key Opinion Leaders
Work Experience
- 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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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Leading multidisciplinary Benefit Risk Teams for rare disease therapies. MD, PharmD, or PhD with 8+ years clinical/pharma R&D experience required. Extensive cross-functional and partner company interaction.
Requirements
- Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
- 8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
- 5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
- Experience leading cross-functional global product safety management teams
- In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
- Experience working with partner companies in global markets
- Experience presenting medical safety information at Health Authority meetings
- Fluency in written and spoken English
- Strong communication and team-leadership capabilities
- Sound judgment skills and ability to assess and handle risks
- Expertise in resolving or escalating issues as appropriate
Tasks
- Lead the multidisciplinary Benefit Risk Team for product safety
- Drive signal detection, analysis, risk management, and safety labeling
- Provide pharmacovigilance and clinical safety expertise at the product level Medical Development Team
- Contribute to clinical development through design, conduct, data analysis, and interpretation
- Oversee safety science interactions with partner companies
- Develop and implement signal management activities
- Provide medical and pharmacovigilance expertise for clinical safety strategy and regulatory documents
- Lead Safety Science input for post-marketing activities and risk minimization measures
- Support regulatory submissions and product expansion activities
- Respond to medical safety-related inquiries and assist with audits and inspections
- Represent Global Pharmacovigilance in interactions with stakeholders, including Regulatory Authorities and Key Opinion Leaders
Work Experience
- 8 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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.
About the Company
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
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