Is Your Adverse Event Case Processing Falling Behind?

An Individual Case Safety Report (ICSR) is a standardised document used to report information about a suspected adverse reaction to a medicine or medical device. It captures details about the patient, the reporter, the suspected product, and the adverse event. ICSRs are submitted to national regulatory authorities within defined timelines and form the foundation of pharmacovigilance surveillance.

A valid ICSR must contain four minimum elements: an identifiable patient (age, gender, or initials), an identifiable reporter (name, address, or contact details), the name of the suspect medicinal product, and a description of the adverse event or reaction. Jeyflex validates all incoming cases against these criteria before processing proceeds.

For serious adverse events, regulatory authorities typically require submission within 7 to 15 calendar days depending on the case type and market. Non-serious cases are generally submitted on a periodic basis. Jeyflex manages all submission timelines to ensure no deadlines are missed across your target African markets.

Yes. Jeyflex provides case management services across 16 African markets — ensuring ICSRs are processed and submitted to the relevant regulatory authority in each market within the required timelines. We provide consolidated reporting and a single point of contact for all markets, reducing operational complexity for your team.

Data quality is maintained through a structured quality review process at each stage of case processing — including validation against minimum ICSR criteria, medical coding review, narrative quality checks, and pre-submission review. Our ISO 9001:2015 certified quality management system provides the framework for consistent, accurate case processing across all engagements.