Your role

You will be responsible for ensure that ICSRs/ADEs with a particular focus on new to market products are processed and distributed/submitted according to local legislations and eventual Safety Data Exchange Agreements and to ensure high compliance is maintained in relation to ICSR legislations worldwide. 

• Receive, review, and ensure completeness of case information and source documents, performing duplicate checks and case triage.


• Accurately enter case data into the database, attach relevant documents, and perform MedDRA and WHO Drug Dictionary coding.


• Write case narratives, assess listedness and causality, and finalize case documentation for distribution/submission.


• Communicate with stakeholders for follow-up information and ensure compliance with follow-up procedures.


• Perform data validation, qualit...