Khaja Ahmeduddin

Background

About Khaja Ahmeduddin

Capturing and assessing single adverse event reports associated with client products on a worldwide basis on the client's drug safety database, in accordance with international and local regulatory requirements. • Hands-on expertise in end-to-end case processing in Pharmacovigilance database AEGIS. • Strong knowledge of MedDRA, WHO drug dictionary and coding practices. • Thorough understanding of adverse event reporting and safety databases. • Good knowledge and understanding of the standard operating procedures and abiding by the guidelines. • Managed Individual Case Safety Reports of all case types (serious and non-serious cases from solicited clinical trial and E2B cases. • Triage of confidential to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities. • Conducting duplicate searches prior to initiation and identifying potential duplicates. • Assessed labelling of serious adverse events originating from clinical sources with reference to IB, CCDS, SmPC and USPI.