Pharmacovigilance Analytics and Reporting Specialist

Summary

The Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence, is responsible for supporting the execution and continuous improvement of analytics, reporting, and operational initiatives aligned with the vision, strategy, and objectives of the Global Biostatistics & Data Sciences (GBDS) function.

This individual contributes to the development, implementation, and delivery of scientific, operational, and regulatory reporting solutions that support Pharmacovigilance (PV)/Patient Safety (PS) business needs. Reporting to the Senior Manager, PV Analytics Center of Excellence, the Specialist will leverage a combination of life sciences knowledge, analytical expertise, and reporting/visualization capabilities to drive data-informed decision-making across Patient Safety.

The ideal candidate will possess strong technical expertise in analytics and reporting tools, excellent problem-solving skills, and the ability to collaborate effectively across cross-functional teams in a fast-paced environment.

Contract Length: 12 months

Location: Hybrid in Princeton, NJ (50% remote)

Responsibilities

Data Analytics & Reporting

• Build, maintain, and continuously improve analytics models and reporting solutions that provide insights into operational efficiency, quality, stakeholder feedback, and key performance indicators (KPIs) to support timely and informed decision-making.
• Develop and maintain reporting databases and analytics applications using tools such as Excel, Tableau, Power BI, SAP Business Objects, and other BMS reporting environments.
• Leverage internal systems and tools to streamline reporting processes and reduce manual data retrieval efforts.
• Utilize data analysis tools to aggregate, analyze, and interpret data in order to generate actionable recommendations and answer critical business questions.
• Generate and maintain routine and ad hoc reports related to activities, outcomes, and trends, and present findings to management as needed.
• Collect, analyze, and summarize data for monthly reporting and quarterly business reviews.
• Maintain data integrity, consistency, and traceability throughout the data lifecycle from source to target systems.
• Define and deliver metrics reporting and analytical insights supporting GBDS and Patient Safety initiatives.

Validation & Process Support

• Partner with validation teams to support the creation of validation documentation, including validation plans, test scripts, and validation summary reports.
• Support program and project teams in implementing innovation and process improvement initiatives.
• Contribute to the prioritization, management, and execution of continuous improvement efforts.
• Analyze stakeholder feedback and operational challenges, collaborating with functional leads to recommend practical and impactful solutions.

Qualifications & Skills

Required Qualifications

• Bachelor's degree required.
• Pharmacovigilance/Drug Safety Experience is highly preferred.
• Advanced experience developing reports in SAP Business Objects (v4.3 preferred).
• Advanced experience creating interactive dashboards and visualizations using Tableau and/or Power BI.
• Advanced SQL skills for data querying, analysis, and reporting.
• Strong proficiency with Microsoft PowerPoint, Word, and Excel.
• Knowledge of validation processes and associated documentation requirements.
• Excellent verbal, written, presentation, and project management skills.
• Strong analytical and strategic thinking capabilities with the ability to translate insights into operational priorities and action plans.
• Ability to manage multiple projects and competing priorities in a fast-paced environment.
• Demonstrated ability to collaborate effectively across cross-functional teams and stakeholders.
• Strong organizational skills with the ability to synthesize and interpret complex or fragmented data.
• High level of professionalism, integrity, and confidentiality.

Preferred Qualifications

• Advanced experience with Spotfire highly preferred.
• Experience with ARISg and Argus is desirable 
• Knowledge of taxonomies, ontologies, and other knowledge management frameworks preferred.

Core Competencies

• Strong problem-solving and decision-making skills.
• Ability to resolve complex stakeholder issues and drive consensus.
• Proven ability to promote teamwork, collaboration, and accountability.
• Ability to support critical path analysis and scenario planning activities.
• Flexible, proactive team player with a positive attitude and strong customer-service orientation.

Compensation: Hourly Pay Range: $50-60 per hour (dependent on W2 vs. 1099)* 

*The hourly rate offered will be commensurate with experience, skills, qualifications, and other relevant factors.

Benefits Overview: For contractors engaged through Summit Strategic Search, eligibility for benefits is determined by the specific terms of the contract and may include:

• Medical, Dental, and Vision insurance options.

• Paid Sick Leave (consistent with applicable state law).

• Paid Time Off (PTO) and/or holiday pay.

About the Search: This search is being managed by Summit Strategic Search on behalf of our client. This is a contract-based assignment where we the recruitment and employment administration. While you will be engaged through our firm, the end client retains final authority over the selection of personnel for their project team. All offers of engagement are contingent upon the end client's approval, project requirements, and successful completion of the onboarding process.

Equal Opportunity Commitment: We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law. 

Accommodations & Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at admin@summitstrategicsearch.com. We maintain a zero-tolerance policy for harassment and provide all contractors with dedicated reporting channels to ensure a safe, professional work environment.

Onboarding Requirements: Due to the regulated nature of our client's industry and the requirement for on-site presence in the Princeton, NJ area, all candidates must successfully complete the end client's onboarding protocols. This typically includes a background check, drug screening, and adherence to site-specific security and health policies.