<ul><li>Identify out of scope activities in conjunction with the MSS Functional Lead.</li><li>Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines.</li><li>Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance.</li><li>Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.</li><li>Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements.</li><li>Perform post surveillance activities such as literature review and media monitoring</li></ul>

Drug Safety Associate