Pharmacovigilance Analytics and Reporting Specialist

4 weeks ago

Lawrence NJ, United States Axelon Full time
Job Summary:

The Pharmacovigilance Analytics and Reporting Specialist at Axelon will be responsible for the successful execution and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics & Data Sciences Function.

Key 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, Spotfire, 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 crossfunctional teams (Pharmacovigilance, Epidemiology, etc.)
• Utilize data analysis tools to aggregate and analyze data to make actional 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 adhoc 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/WWPS initiatives including relevant insights to facilitate decisionmaking process
• Assess and interpret the process impact of new PV tools and processes

Requirements:

• Life Sciences, Information, or similar background (Bachelors, Masters)
• 5+ years Drug Safety/Pharmacovigilance experience
• Advanced Tableau, Spotfire, Power BI, SAP Business Objects (BO) skills with 5+ years of development experience
• Databases (Postgres, Oracle, MS Access, Impala, SharePoint List etc.)
• Programming languages (SQL, VBA, Python etc.)
• Reporting platforms and services (Cognos, SAP-Business Objects, Power BI etc.)
• Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug)
• Ability to organize/curate data and see big picture from scattered pieces of information
• 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
• Ability to lead the development of critical path analyses and support scenario planning
• Promotes and practices effective proactive decisionmaking, ensuring timely coordination and dissemination of information
• Demonstrated ability to work on multiple projects
• Strong willingness to collaborate with crossfunctional partners
• Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities
• Confidentiality and integrity are required

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