• Pharmacovigilance Reports Analyst

    Job Locations - | US-IL-Chicago
    Posted Date 1 month ago(7/17/2018 10:15 AM)
  • Overview

    • Support expertise within the Global Pharmacovigilance group for implementation / operation of all ISIS Global reporting solutions
    • Work collaboratively with Global Pharmacovigilance functions, Global PV Database Reporting and Analytics Lead, support and validation roles, IT teams and Quality Assurance to ensure excellent and efficient Global reporting systems and end-user support
    • Support / contribute to planning, roadmap, and execution of the Global PV Database reporting and analytics systems’ requirements, ensuring Global regulatory requirements are met
    • Support oversight of any vendor outsourced Global PV reporting activities
    • Support interface to Global PV alliance partners, representing Global PV DB Reporting and Analytics technologies / content


    • Collaborate proactively with Global Pharmacovigilance reporting end-users to identify / document business needs and requirements
    • Support Global Pharmacovigilance Alliance partner management in all facets of Global PV DB reporting technologies and content
    • Support interface with IT, representing/articulating Global PV DB reporting technology requirements
    • Contribute to development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc) in response to Global Pharmacovigilance requirements and related driving Regulatory guidance
    • Contribute to performance of user needs / requirements analysis, supporting build / maintenance of BI solutions, using Oracle, Cognos, and/or other applicable technologies, including definition of requirements, designs, source code development, testing, maintenance, and migration
    • Support prioritization, planning / scheduling, and execution of Global custom report and/or Global ad hoc query development
    • Support prioritization, planning / scheduling, and/or execution of global reports
      • Support system and data investigations, resulting from end-user inquiry and/or Global Pharmacovigilance requirements
      • Contribute to definition/documentation of Global reporting development and related process standards, procedures, and best practices
      • Contribute to implementation of automated processes, yielding improved overall efficiency in all areas of Global PV Reporting and Analytics service delivery
      • Contribute to audit / inspection support related to Global PV Reporting and Analytics
      • Contribute to development, tracking, and reporting of quality metrics for Global reports
      • Support Global PV DB Reporting and Analytics technology project teams as required
      • Support development and/or delivery of related training/training materials to identified training audiences


    • Bachelors degree required
    • Experience with Pharmacovigilance Drug Safety and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc preferred) business support and/or maintenance
    • Knowledge of database query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc
    • Understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing
    • Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment
    • Process oriented focus
    • General knowledge of drug development process, including knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
    • Prior project management experience a plus
    • Strong analytical skills
    • Excellent written and verbal communication skills
    • Strong organizational and time management skills
    • Working knowledge of MedDRA
    • Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds
    • Support management / oversight of outsourced Global PV reporting activities
    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.


    **Located in Deerfield, IL - with work from home capabilities**


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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