C08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST

ECLARO; Lawrenceville (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to delivering life-changing healthcare solutions as a Pharmacovigilance Analytics and Reporting Specialist. In this role, you will leverage your expertise in data analysis and visualization tools to enhance operational efficiency and contribute to regulatory reporting efforts. Collaborating with cross-functional teams, you'll ensure data integrity and provide actionable insights that drive innovation. If you're passionate about making a difference in the healthcare industry and possess strong analytical and communication skills, this is the perfect opportunity for you to thrive in a dynamic environment.

Benefits

401k Plan

Pretax Commuter Benefits

Insurance Options

Qualifications

• 5+ years experience in Drug Safety/Pharmacovigilance preferred.
• Strong organizational, analytical, and strategic thinking skills.

Responsibilities

• Build and improve data analytics models for insights into efficiency and quality.
• Prepare reports on activities and outcomes; deliver presentations to management.

Skills

Data Analysis

Project Management

Communication Skills

Analytical Thinking

Confidentiality

Education

Bachelor's in Life Sciences

Master's in Life Sciences

Tools

SAP Business Objects

Tableau

Power BI

SQL

Excel

Job description

Pharmacovigilance (PV) Analytics and Reporting Specialist

Be part of a company that delivers life-changing healthcare solutions. ECLARO is seeking a Pharmacovigilance (PV) Analytics and Reporting Specialist for our client in Lawrenceville, NJ.

Position Overview:

• Responsible for the successful execution and close-out of activities aligned with the vision, strategy, and objectives of the Global Biostatistics & Data Sciences Function.
• Contributes to the development, implementation, and execution of scientific, operational, and regulatory reporting efforts.
• Reports to the Senior Manager, PV Analytics Center of Excellence within Global Biostatistics & Data Sciences.
• Uses life sciences strategy, leadership, and reporting/visualization experience to service information needs across PS.

Responsibilities:

• Build and improve data analytics using models that provide insights into efficiency, quality, stakeholder feedback, and KPIs.
• Maintain and develop reporting databases and analytics applications in environments such as Excel, Tableau, Power BI, SAP Business Objects.
• Leverage internal data systems to maintain data and reporting processes efficiently.
• Collaborate with validation team to create validation test scripts, plans, and reports.
• Contribute to research projects through data trend analysis from cross-functional teams.
• Use data analysis tools to make actionable recommendations and answer business questions.
• Prepare reports on activities and outcomes; deliver presentations to management.
• Collect data for monthly reports and quarterly reviews.
• Stay informed about changes in the healthcare industry affecting analytical programs.
• Address stakeholder complaints and collaborate on solutions.
• Ensure data integrity and traceability throughout the lifecycle.
• Support program activities for innovation initiatives.
• Contribute to process improvement and innovation prioritization.
• Define and provide metric reporting for GBDS/PS initiatives.
• Assess the impact of new PV tools and processes.

Minimum Requirements:

• Background in Life Sciences, Information, or similar (Bachelors, Masters).
• 5+ years in Drug Safety/Pharmacovigilance preferred.
• Advanced skills in SAP Business Objects, Tableau or Power BI, SQL.
• Knowledge of MedDRA, WHO Drug coding dictionaries.
• Strong organizational, analytical, and strategic thinking skills.
• Excellent communication and project management skills.
• Knowledge of validation processes and documentation.
• Ability to work on multiple projects and collaborate effectively.
• Confidentiality and integrity are essential.

If hired, you will enjoy benefits such as a 401k plan, pretax commuter benefits, and insurance options. To express interest, contact Jane Bautista at [e-mail] or 3322060772.