Amgen
From Amgen's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
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
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 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
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
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
.
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