Global Pharmacovigilance Reporting & Analytics Lead ( Remote Role)

Radiant Systems Inc; EUA; Teletrabalho; USD 117 000 - 138 000; Tempo parcial

Resumo da oferta

Radiant Systems Inc. seeks a Global Pharmacovigilance Reporting & Analytics Lead for a remote, 6-month W2 engagement with a major pharmaceutical client in the United States. You will own PV reporting solutions, lead BI development, and collaborate with global teams to ensure compliant, scalable reporting and analytics.

Requirements include 5+ years in PV data systems, strong Oracle SQL, and experience with Argus and Cognos. SDLC, 21 CFR Part 11, and GMP/GxP familiarity are essential.

Qualificações

• Bachelor's degree required; advanced degree preferred.
• 5+ years of technical systems experience in DB reporting/BI/data warehousing.
• Experience with Pharmacovigilance drug safety systems (Argus, Cognos, Spotfire, SSRS).
• Expert knowledge of Oracle SQL/PL-SQL and scripting.
• Solid SDLC understanding and GMP/GxP validation experience.

Responsabilidades

• Identify end-user PV reporting needs and requirements.
• Develop and maintain BI reporting capabilities (reports, dashboards, analytics).
• Lead data investigations and ad hoc report development.
• Support validation and regulatory compliance for PV reporting systems.
• Mentor and train junior report developers.

Conhecimentos

Argus Safety Database

SQL

Systems Validation & GxP Knowledge

Formação académica

Bachelor's degree

Advanced degree preferred

Ferramentas

Argus Safety

Cognos

Spotfire

SSRS

Descrição da oferta de emprego

Client: Major Pharmaceutical Client

Position: Global Pharmacovigilance Reporting & Analytics Lead ( Remote Role)

Duration: 6 Months on W2

Location: REMOTE

Pay Rate: $85 - $100.00/Hr on W2

Top 3 Skills

• Argus Safety Database
• SQL
• Systems Validation & GxP Knowledge

Objective / Purpose

• Provide expertise within the Global Pharmacovigilance group for the implementation and 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 Global PV Database reporting and analytics systems' requirements, ensuring Global regulatory requirements are met.
• Contribute to oversight of outsourced Global PV reporting activities.

Accountabilities

• Proactively identify and document Global Pharmacovigilance reporting end-user system needs and requirements.
• Provide strategic technical input into the development of roadmaps and plans for implementing a complete range of Business Intelligence (BI) capabilities (reporting, analysis, dashboards, etc.) in response to Global Pharmacovigilance requirements and related regulatory guidance.
• Lead and perform user needs and requirements analysis, supporting the build and maintenance of BI solutions using Oracle, Cognos, and/or other applicable technologies, including requirements definition, design, source code development, unit testing, maintenance, and migration.
• Lead and execute tuning and optimization of Global reporting solutions, including identifying and mitigating risks in proposed solutions.
• Lead and 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 inquiries and/or Global Pharmacovigilance requirements.
• Provide strategic technical input into the definition and documentation of Global reporting development and related process standards, procedures, and best practices.
• Research and/or contribute to the implementation of automated processes, driving improved overall efficiency in all areas of Global PV Reporting and Analytics service delivery.
• Perform audit and inspection support related to Global PV Reporting and Analytics.
• Develop, track, and report quality metrics for Global PV reports.
• Provide strategic technical input and support for 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.

Job Requirements

• Bachelor's degree required; advanced degree preferred.
• 5+ years of technical systems experience required, preferably in Database Reporting, Development, Business Intelligence, or Data Warehousing.
• Experience with Pharmacovigilance Drug Safety Systems, including underlying database data models and associated Business Intelligence Reporting Systems (Argus, Insight, Cognos, Spotfire, SSRS preferred), including 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, 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 the drug development process, including excellent knowledge of Pharmacovigilance regulations and guidance as applicable 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, across various functions and with a wide variety of disciplines and backgrounds.
• Ability to contribute to oversight of outsourced Global PV reporting activities.