Senior Associate Safety Data Analyst

**Career Category** ------------------- Engineering **Job Description** ------------------- **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 .