Senior Drug Safety Associate

As a Sr Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for client marketed products and clinical trials. Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. Perform case processing (including case deactivations) and data gathering tasks within Argus Safety Database and other client systems (i.e. EDC systems). Assist with literature review and article procurement as required. Perform retrospective quality review and document findings, and contribute to metric compilation. Assist with business partner and other query management. Represent Pharmacovigilance on project teams. Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes. Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required. Train and mentor case processing staff. Assist with creating procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes. Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.