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
