Pharmacovigilance Database Reporting Lead

Job Description:

Top 3 skills: Argus Safety Database; SQL; Systems Validation & GxP Knowledge.

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

Education & Competencies (Technical and Behavioral):

• 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