Duration: 05 months Contract Objective: • Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) database • Provide technical and strategic input into the roadmap, planning, and implementation of projects associated with the global PV database reporting and analytics systems • Work collaboratively with global PV functions, support and validation roles, IT and Quality Assurance to ensure global PV reporting systems meet the needs of the user community and relevant regulations • Contribute to oversight of vendor outsourced PV reporting activities Duties: • Lead delivery of PV reporting and analytics systems projects in coordination with IT • Lead selection and delivery of new applications to support self-service reporting and analysis of PV data • Lead continuous improvement to PV reporting and analytics systems with focus on integration of (external) data sources, automation, and industry standard dashboards • Provide SME input into development of roadmaps / plans for implementing complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.) in response to global PV requirements and related driving regulatory guidance • Develop and ensure delivery of relevant PV reporting and analytics systems SOPs and training • Proactively identify PV reporting and analytics systems requirements in collaboration with business, IT, Quality, and other stakeholders • Provide mentoring and training to members of the PV Systems team and GPSE user community to build a bench of knowledge at varying levels throughout the organization • Perform audit / inspection support related to Global PV Reporting and Analytics functions and activities • Development, tracking, and reporting of quality metrics for Global PV reports Qualifications: • Bachelor’s degree required; Advanced degree preferred • Experience with Pharmacovigilance Drug Safety Systems, including underlying DB data models, and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS, etc 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 TRAVEL REQUIREMENTS: • Some travel to global sites may be required. ADDITIONAL INFORMATION: • Minimum of 10 years pharmaceutical or healthcare related industry experience required • Minimum of 5 years pharmacovigilance or drug safety related experience • Minimum of 5 years technical systems experience required in database report development, business intelligence, and/or data warehousing About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Swati Email: swati.tiwari@ustechsolutionsinc.com Internal Id: 25-42172