Bavarian Nordic GmbH
Head of Medical Safety GCSP(m/w/x)
Vollzeitmit HomeofficeSenior
Martinsried
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CACatalYm
Senior Safety Physician(m/w/x)
München
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
Leading global drug safety strategy and medical expertise for clinical development programs. Over 5 years of global clinical safety experience with biologics required. Flexibility and professional growth opportunities.
Requirements
- MD with practical patient care experience
- More than 5 years clinical Safety experience with global trials in pharmaceutical industry (preferably including biologics)
- Familiarity with Safety relevant ICH Guidelines and ICHE6(R3)
- Familiarity with EU and FDA Safety reporting requirements
- Fluent English (writing and speaking)
- Based in Munich area with approx. 2 days/week in office
Tasks
- Lead strategic direction for Clinical Drug Safety
- Oversee safety profile evaluation of products
- Shape and implement safety standards
- Drive safety strategy for clinical development programs
- Provide medical expertise in safety surveillance
- Create and update development risk management plans
- Evaluate and manage project risks
- Recommend risk communication strategies
- Lead Signal Detection process for CatalYm projects
- Produce high-quality safety documents
- Review serious adverse event reports
- Assess sponsor causality and expectedness
- Implement Safety Data Exchange Agreements
- Respond to safety queries from all sources
- Provide medical expertise for trial protocols
- Prepare investigators' brochures and letters
- Lead safety analyses of assigned projects
- Contribute to development of relevant SOPs
- Ensure high-quality safety responses
- Own CatalYm Safety System within Quality Management System
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Fluent
Benefits
Flexible Working
- Flexibility
Competitive Pay
- Ownership
Career Advancement
- Professional growth
Informal Culture
- Supportive culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CatalYm 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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CACatalYm
Senior Safety Physician(m/w/x)
München
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
Leading global drug safety strategy and medical expertise for clinical development programs. Over 5 years of global clinical safety experience with biologics required. Flexibility and professional growth opportunities.
Requirements
- MD with practical patient care experience
- More than 5 years clinical Safety experience with global trials in pharmaceutical industry (preferably including biologics)
- Familiarity with Safety relevant ICH Guidelines and ICHE6(R3)
- Familiarity with EU and FDA Safety reporting requirements
- Fluent English (writing and speaking)
- Based in Munich area with approx. 2 days/week in office
Tasks
- Lead strategic direction for Clinical Drug Safety
- Oversee safety profile evaluation of products
- Shape and implement safety standards
- Drive safety strategy for clinical development programs
- Provide medical expertise in safety surveillance
- Create and update development risk management plans
- Evaluate and manage project risks
- Recommend risk communication strategies
- Lead Signal Detection process for CatalYm projects
- Produce high-quality safety documents
- Review serious adverse event reports
- Assess sponsor causality and expectedness
- Implement Safety Data Exchange Agreements
- Respond to safety queries from all sources
- Provide medical expertise for trial protocols
- Prepare investigators' brochures and letters
- Lead safety analyses of assigned projects
- Contribute to development of relevant SOPs
- Ensure high-quality safety responses
- Own CatalYm Safety System within Quality Management System
Work Experience
- 5 years
Education
- Doctoral / PhD
Languages
- English – Fluent
Benefits
Flexible Working
- Flexibility
Competitive Pay
- Ownership
Career Advancement
- Professional growth
Informal Culture
- Supportive culture
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CatalYm 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
CatalYm
Industry
Pharmaceuticals
Description
CatalYm is a biotech company developing innovative immunotherapies to transform cancer patients’ lives.
Noch nicht perfekt?
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