Idorsia Pharmaceuticals Ltd
Drug Safety Scientist(m/w/x)
Full-timeOn-siteSenior
Allschwil
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Pharmacovigilance and safety oversight for drug development lifecycle. Healthcare professional or Life Sciences postgraduate with 4 years drug development and 2 years drug safety experience required. Work focused on advancing science and healthcare access.
Requirements
- Healthcare professional, Life Sciences graduate, or postgraduate qualification
- Four years drug development experience and two years drug safety
- Understanding of GxP and clinical trial lifecycle
- Excellent written and verbal communication skills
- Complex data analysis and statistical methods proficiency
- Strong presentation and summarization skills
- Ability to work independently and manage safety responsibilities
Tasks
- Provide safety science and pharmacovigilance support
- Influence early and late-phase development activities
- Offer safety oversight for study management
- Lead signal evaluation and benefit-risk assessments
- Manage comprehensive safety risk activities
- Oversee individual and aggregate case reporting
- Prepare DSUR and PBRER aggregate reports
- Drive signal detection and management processes
- Maintain STAR and ISMP documentation
- Contribute to the Clinical Development strategy
- Prepare CCDS and labeling documents
- Develop risk communications, RMP, and REMS
- Identify personal and professional development areas
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GxP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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Pharmacovigilance and safety oversight for drug development lifecycle. Healthcare professional or Life Sciences postgraduate with 4 years drug development and 2 years drug safety experience required. Work focused on advancing science and healthcare access.
Requirements
- Healthcare professional, Life Sciences graduate, or postgraduate qualification
- Four years drug development experience and two years drug safety
- Understanding of GxP and clinical trial lifecycle
- Excellent written and verbal communication skills
- Complex data analysis and statistical methods proficiency
- Strong presentation and summarization skills
- Ability to work independently and manage safety responsibilities
Tasks
- Provide safety science and pharmacovigilance support
- Influence early and late-phase development activities
- Offer safety oversight for study management
- Lead signal evaluation and benefit-risk assessments
- Manage comprehensive safety risk activities
- Oversee individual and aggregate case reporting
- Prepare DSUR and PBRER aggregate reports
- Drive signal detection and management processes
- Maintain STAR and ISMP documentation
- Contribute to the Clinical Development strategy
- Prepare CCDS and labeling documents
- Develop risk communications, RMP, and REMS
- Identify personal and professional development areas
Work Experience
- 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GxP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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
Roche
Industry
Healthcare
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- Idorsia Pharmaceuticals Ltd
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