Pharmacovigilance (PV) Analytics and Reporting Specialist

Position Overview

The Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence is responsible for executing and closing out activities aligned with the global biostatistics and data sciences function. This role contributes to the development, implementation, and execution of scientific, operational, and regulatory reporting efforts in line with the overall pharmacovigilance needs.

Responsibilities

• Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making
• Maintain and develop reporting databases and analytics applications in environments such as Excel, Tableau, Power BI, SAP Business Objects and/or other client environments
• Leverage internal data systems and tools to efficiently maintain data and reporting processes to minimize manual data retrieving
• Liaison with validation team to create validation test script, validation plan, validation summary report and test scripts. Contribute to qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Pharmacovigilance, Epidemiology, etc.)
• Utilize data analysis tools to aggregate and analyze data to make actionable recommendations and answer key business questions
• Run and maintain reports regarding activities, outcomes, and be prepared to deliver presentations to management team on a regular and ad-hoc basis
• Collect data for monthly reports and quarterly reviews regarding activities, outcomes, and trends of the Advisor team
• Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our analytical programs and reporting mechanisms
• Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions
• Maintain data integrity and traceability across the transformation lifecycle from the Source to Target
• Support program and project team activities required to implement innovation initiatives. Contribute to the management and prioritization of process improvement and innovation initiatives
• Define and provide metric reporting and data analysis for GBDS/PS initiatives including relevant insights to facilitate decision-making process
• Absess and interpret the process impact of new PV tools and processes

Required Skills

• Life Sciences, Information, or similar background (Bachelors, Masters)
• Advanced experience with creating reports in SAP Business Objects
• Advanced Tableau or Power BI experience in creating interactive dashboards
• Advanced SQL experience for data querying
• Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug)
• Knowledge of taxonomies, ontologies, and other knowledge management constructs
• Analytical and strategic thinking skills required
• Strong PowerPoint, Word, and Excel Skills
• Knowledge of Validation processes and associated documentation
• Excellent verbal, writing, presentation, and project management skills
• Strong strategic orientation with ability to translate into operational priorities and plans
• Ability to promote cooperation and commitment within a team to achieve goals and deliverables
• Ability to resolve complex problems and manage difficult stakeholder situations
• Strong willingness to collaborate with cross-functional partners
• Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities