The role involves assisting with the collection, processing, and reporting of individual cases safety reports (ICSRs) while adhering to strict regulatory guidelines
Job Summary
The role involves assisting with the collection, processing, and reporting of individual cases safety reports (ICSRs) while adhering to strict regulatory guidelines.
Syneos Health is committed to a Total Self culture where employees can authentically be themselves and collaborate as passionate problem solvers.
Candidates must have a Bachelor's degree in life sciences or nursing along with at least four years of specific experience in ICSR case processing.
Matching Summary
The role involves assisting with the collection, processing, and reporting of individual cases safety reports (ICSRs) while adhering to strict regulatory guidelines.
Skills & Requirements
Must-have
4+ years ICSR case processing experience
MedDRA coding proficiency required
Safety database systems knowledge
Medical terminology expertise
GCP and GVP regulatory compliance
Nice-to-have
Signal detection management experience
Advanced MedDRA coding training
Clinical trial process understanding
Excellent communication skills
Ability to work independently
Key Requirements
Bachelor's Degree in life science, nursing, or pharmacy
Minimum 4 years of ICSR case processing experience
Proficiency in Microsoft Office Suite and safety databases