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

• 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

• 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