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
.