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 .