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 .