SAFETY & PHARMACOVIGILANCE

—Preparation of customized drug safety and pharmacovigilance SOPs

—Preparation of Safety Management Plan

—Registration of Sponsors in the EMEA EudraVigilance database

—Registration of the medicinal products in the XEVMPD

—XEVMPD information to EudraVigilance via EVWEB

—Participation in global safety meetings with the Competent Authorities

—SAE coding, management and Expedited reporting: Collection, Quality Control, Assessment, narrative writing, unblinding and management of ICSRs

—MedDRA coding of non-serious AEs

—SUSAR submission package for investigators & Ethics committees

—Periodic Safety Reporting: Development Safety Update Reports (DSUR) and Periodic Safety

—Update Reports (PSURs)

—CIOMS II Line listings management