Serious and unexpected suspected adverse reaction (susar) reporting
Johnson & Johnson is seeking a Manager of Case Processing in Allschwil, Switzerland, to lead a team responsible for processing Clinical Trial Individual Case Safety Reports (ICSRs). The ideal candidate will have significant experience in pharmacovigilance, strong leadership skills, and a commitment to regulatory compliance
Job Summary
The Manager, Case Processing directs and oversees the operational and people management activities of a team of Drug Safety Associates responsible for processing investigational Clinical Trial (CT) Individual Case Safety Reports (ICSRs).
This role partners closely with Global Medical Safety Operations functions and Clinical Development organizations to enable compliant, timely, and efficient end-to-end management of investigational CT ICSRs.
Key responsibilities include managing and supporting team members, ensuring quality and regulatory compliance of processed ICSRs, and leading resource planning and allocation activities.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Manager of Case Processing in Allschwil, Switzerland, to lead a team responsible for processing Clinical Trial Individual Case Safety Reports (ICSRs). The ideal candidate will have significant experience in pharmacovigilance, strong leadership skills, and a commitment to regulatory compliance.
Skills & Requirements
Must-have
Drug Safety Associates (DSAs)
Investigational Clinical Trial ICSRs
Serious and Unexpected Suspected Adverse Reaction (SUSAR) reporting
Global Medical Safety Operations
Pharmacovigilance regulations
Nice-to-have
Coaching and performance management
Resource planning and allocation
Subject-matter expert in clinical trial case processing
Credo-based values and ethical decision-making
Key Requirements
Bachelor’s degree in a health-related or scientific discipline
Minimum of 5 years of pharmaceutical industry or clinical experience
Demonstrated knowledge of global safety reporting regulations