**Group Purpose:** This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations. **Job Summary:** + Support changes to the global safety system and associated Datamart + Support the implementation of global safety system configurations + Support accurate clinical trial safety data collection in the global safety system **Key Activities:** With limited direction from Sr. Manager-Safety Data Analyst (SDA), the Sr. Associate - SDA may perform the following activities: + Generate outputs from the global safety system in support of + periodic safety reports (e.g., PADER, PSUR, DSUR) + signal detection + audits, inspections and regulatory inquires + Ensure delivery of automated/scheduled safety data outputs + Perform Quality Checks/Peer Review as needed for data outputs and routine system configurations + Participate in collecting business requirements for routine safety data outputs + Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration + Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs + Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW)
approval + Participate in user UAT of safety system changes + Contribute to the development and maintenance of technical solutions to support safety system and data outputs + Participate in the development and delivery of training related to safety database and tools + Assist in the development of system support related quick reference guides. + Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness + Support Authority Inspection and Internal Process Audits within the remit of role and responsibility **Knowledge and Skills:** + Knowledge of safety systems (LifeSphere MultiVigilance platform/Argus) as well as query and reporting tools e.g. Cognos, Tableau + Understanding of data warehouse concepts and data mining techniques + Understanding of software development lifecycle and development standards, including validation methodology + Understanding of global regulatory requirements for pharmacovigilance and safety reporting + Understanding of Clinical Trial and Pharmacovigilance Processes + Familiarity with statistical analysis and interpretation of aggregate safety data + Organization, prioritization, planning and measurement of work deliverables + Ability to build relationships and work cross-functionally + Work independently and proactively; recognize and escalate issues + Pharmaceutical industry or health authority experience. + Experience in supporting inspections or internal audits **Education & Experience (Basic):** + Master's degree + OR + Bachelor's degree and 2 years of directly related experience + OR + High school diploma / GED and 8 years of directly related experience **Education & Experience (Preferred):** + Work experience in biotech/pharmaceutical industry + Database support work experience + Understanding of clinical trial databases such as Rave/Veeva EDC + Understanding of integration between clinical trial databases and safety databases