Novartis
Global Program Safety Team Lead(m/w/x)
Full-timeOn-siteSenior
Basel
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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