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# Lead Report Developer, PV Systems, Reporting, & Analytics Group

- **Company:** Spectraforce
- **Location:** United States (Remote available)
- **Experience:** Expert
- **Contract:** Temporary contract
- **Skills:** Microsoft Windows, Data Analysis, Unit Testing, Databases, Data Systems, Data Warehousing, IBM Cognos Business Intelligence, Unix Shell, Oracle (Applications), Oracle SQL Developer, Software Engineering, PL-SQL, SQL Databases, SQL Server Reporting Services, Information Technology, Spotfire, Software Coding, GXP, Database Tools and Utilities, Custom Reports
- **Published:** November 12, 2026
- **Apply:** http://leoforce.us/Careers/Spectraforce/JobDetails.html?jobid=cccc0f9d-b8a4-4b82-b6c1-d4f84548b6c6&OrgId=1&UserId=2772

## About the Role

* Bachelor's degree required; Advanced degree preferred
 * 5 - 8 years of technical systems experience required; preferably in Database Reporting,
 * Development, Business Intelligence, or Data Warehousing
 * Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS preferred) business support and/or maintenance
 * Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, Windows and/or Unix Shell scripting, etc.
 * Strong 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 excellent knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems
 * Excellent analytical skills
 * Excellent written and verbal communication skills
 * Excellent 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
 * Contribute to oversight of outsourced Global PV reporting activities

## Description

* Provide expertise within the Global Pharmacovigilance group for implementation / operation of all 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
 * Provide strategic technical input into planning, roadmap, and execution of the Global PV
 * Database reporting and analytics systems' requirements, ensuring Global regulatory requirements are met
 * Contribute to oversight of any vendor outsourced Global PV reporting activities

Accountabilities:

 * Proactively identify / document Global Pharmacovigilance reporting end-user system needs and requirements
 * Provide strategic technical input into 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
 * Lead / perform 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, unit testing, maintenance, and migration
 * Lead / execute tuning / optimization of Global reporting solutions, including identifying / mitigating risks in proposed solutions
 * Lead / execute Global custom report and/or Global ad hoc query development
 * Contribute to prioritization, planning, and execution of global reports
 * Lead complex Global system and data investigations, supporting end-user inquiry and/or Global Pharmacovigilance requirements
 * Provide strategic technical input into the definition / documentation of Global reporting
 * development and related process standards, procedures, best practices
 * Research and/or contribute to implementation of automated processes, driving improved
 * overall efficiency in all areas of Global PV Reporting and Analytics service delivery
 * Perform audit / inspection support related to Global PV Reporting and Analytics
 * Development, tracking, and reporting of quality metrics for Global PV reports
 * Provide strategic technical input / support of Global PV DB Reporting and Analytics technology projects as required
 * Provide mentoring, training and best practices for ad-hoc query and other Global report developers

Top 3 skills:

 * Argus Safety Database; SQL; Systems Validation & GxP Knowledge