Pharmacovigilance Specialist Lawrenceville NJ New Brunswick NJ

Pharmacovigilance Specialist

Position is Onsite (Lawrenceville/New Brunswick NJ)

Duration: 12 months

OnSite

The Pharmacovigilance (PV) Analytics and Reporting Specialist PV Analytics Center of Excellence is responsible for successful execution and closeout of activities aligned with the overall vision strategy and objectives of the Global Biostatistics & Data Sciences Function. The PV Analytics and Reporting Specialist PV Analytics Center of Excellence contributes to the ongoing development implementation and successful execution of the scientific operational and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist reports to the Senior Manager PV Analytics Center of Excellence within Global Biostatistics & Data Sciences. The PV Analytics and Reporting Specialist PV Analytics Center of Excellence applies a combination of life sciences strategy leadership and reporting/visualization experience to drive successful servicing of information needs across WWPS.

Responsibilities include but are not limited to the following:

Data Analytics and Reporting:

• 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 BMS 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

Skills/Knowledge Required:

• 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 SAPBusiness 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

Arun Kumar

Talent Acquisition Manager

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