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
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Support the implementation of global safety system configurations
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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:
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Generate outputs from the global safety system in support of
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periodic safety reports (e.g., PADER, PSUR, DSUR)
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signal detection
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audits, inspections and regulatory inquires
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Ensure delivery of automated/scheduled safety data outputs
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Perform Quality Checks/Peer Review as needed for data outputs and routine system configurations
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Participate in collecting business requirements for routine safety data outputs
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Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration
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Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs
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Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval
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Participate in user UAT of safety system changes
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Contribute to the development and maintenance of technical solutions to support safety system and data outputs
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Participate in the development and delivery of training related to safety database and tools
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Assist in the development of system support related quick reference guides.
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Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
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Support Authority Inspection and Internal Process Audits within the remit of role and responsibility
Knowledge and Skills:
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Knowledge of safety systems (LifeSphere MultiVigilance platform/Argus) as well as query and reporting tools e.g. Cognos, Tableau
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Understanding of data warehouse concepts and data mining techniques
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Understanding of software development lifecycle and development standards, including validation methodology
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Understanding of global regulatory requirements for pharmacovigilance and safety reporting
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Understanding of Clinical Trial and Pharmacovigilance Processes
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Familiarity with statistical analysis and interpretation of aggregate safety data
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Organization, prioritization, planning and measurement of work deliverables
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Ability to build relationships and work cross-functionally
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Work independently and proactively; recognize and escalate issues
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Pharmaceutical industry or health authority experience.
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Experience in supporting inspections or internal audits
Education & Experience (Basic):
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Master’s degree
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OR
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Bachelor’s degree and 2 years of directly related experience
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OR
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High school diploma / GED and 8 years of directly related experience
Education & Experience (Preferred):
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Work experience in biotech/pharmaceutical industry
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Database support work experience
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Understanding of clinical trial databases such as Rave/Veeva EDC
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Understanding of integration between clinical trial databases and safety databases
