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
.