Senior Associate Safety Data Analyst

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 DatamartSupport the implementation of global safety system configurationsSupport accurate clinical trial safety data collection in the global safety systemKey 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 ofperiodic safety reports (e.g., PADER, PSUR, DSUR)signal detectionaudits, inspections and regulatory inquiresEnsure delivery of automated/scheduled safety data outputsPerform Quality Checks/Peer Review as needed for data outputs and routine system configurationsParticipate in collecting business requirements for routine safety data outputsParticipate in the implementation of routine system configuration including reporting rule updates, product and study configurationAugment and/or define search strategies in collaboration with leads to ensure consistent data outputsSupport study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approvalParticipate in user UAT of safety system changesContribute to the development and maintenance of technical solutions to support safety system and data outputsParticipate in the development and delivery of training related to safety database and toolsAssist 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 readinessSupport Authority Inspection and Internal Process Audits within the remit of role and responsibilityKnowledge and Skills: Knowledge of safety systems (LifeSphere MultiVigilance platform/Argus) as well as query and reporting tools e.g. Cognos, TableauUnderstanding of data warehouse concepts and data mining techniquesUnderstanding of software development lifecycle and development standards, including validation methodologyUnderstanding of global regulatory requirements for pharmacovigilance and safety reportingUnderstanding of Clinical Trial and Pharmacovigilance ProcessesFamiliarity with statistical analysis and interpretation of aggregate safety dataOrganization, prioritization, planning and measurement of work deliverablesAbility to build relationships and work cross-functionallyWork independently and proactively; recognize and escalate issuesPharmaceutical industry or health authority experience.Experience in supporting inspections or internal auditsEducation & Experience (Basic): Masters degreeORBachelors degree and 2 years of directly related experienceORHigh school diploma / GED and 8 years of directly related experienceEducation & Experience (Preferred): Work experience in biotech/pharmaceutical industryDatabase support work experienceUnderstanding of clinical trial databases such as Rave/Veeva EDCUnderstanding of integration between clinical trial databases and safety databases .