Lead Report Developer, PV Systems, Reporting, & Analytics Group
Spectraforce
Cambridge, Massachusetts
Remote
3 days ago
Job Description
Title: Lead Report Developer, PV Systems, Reporting, & Analytics Group Duration: 6 months Location: Remote
Objective / Purpose:
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
Education & Competencies (Technical and Behavioral):
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
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $75.00/hr - $80.00/hr.
