Drug Safety Coordinator

This role involves information management and pharmacovigilance: Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation. Work directly with internal and external clients to request additional information or clarification as necessary; Review patient information in database and ensure accurate documentation as per client needs; Attach Post Infusion Reports to databases to ensure proper documentation for patient assistance and drug safety program needs; Data entry into program specific databases and Quality Management System; Sorting, filing and review of incoming faxes and documents; Assist in processing translation of documents; Perform quality check on adverse event reports as directed by the work instructions; Assist in literature search and review activities; Perform reconciliation activities with internal and external clients/partners; Conduct follow-up and clarification seeking activities as required to ensure completeness of safety reports. The Drug Safety Coordinator will also be assigned other duties and tasks as required from time to time. May be required to be on standby/on call as part of this role.