At a glanceSummarised by Seekless from the posting.
Must have14
Master’s degree
Bachelor’s degree and 2 years of directly related experience
High school diploma / GED and 8 years of directly related experience
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
Nice to have4
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
Skills
LifeSphere MultiVigilance
Argus
Cognos
Tableau
Rave
Veeva EDC
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
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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:
•
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