Remote Pharmacovigilance Analytics & Reporting Specialist

Virtual Company; Cambridge (MA); Teletrabalho; USD 96 000 - 132 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Referral Bonus

Resumo da oferta

The Fountain Group is seeking a Pharmacovigilance Reporting & Analytics Consultant for a fully remote US role. The position focuses on supporting and enhancing PV reporting and analytics systems, including Argus Safety, with a strong emphasis on data-driven insights.

Responsibilities include gathering business requirements, designing and developing reporting solutions, and validating systems to meet 21 CFR Part 11 and GxP standards, while leading UAT and collaborating across PV, IT, QA, and

Qualificações

• Bachelor's degree is required.
• 5-8 years of technical systems experience in Database Reporting, BI, Data Warehousing or related areas is required.
• Experience supporting Pharmacovigilance Drug Safety Systems (Argus Safety preferred) is required.
• Expert-level experience with Oracle SQL, PL/SQL, database querying, and Unix/Windows Shell scripting is required.
• Strong SDLC experience including requirements gathering, technical design, testing, and UAT is required.
• Experience with Computer Systems Validation, GxP compliance, and 21 CFR Part 11 regulated environments is required.
• Advanced degree is preferred.
• Experience with Cognos, Spotfire, SSRS, Insight, MedDRA, and Pharmacovigilance reporting systems is preferred.

Responsabilidades

• Support and enhance Global Pharmacovigilance reporting and analytics systems, including Argus Safety reporting solutions.
• Gather business requirements, design and develop reporting solutions, and support end-user reporting needs.
• Develop, maintain, and optimize database reporting solutions using Oracle SQL and PL/SQL.
• Support validation activities, GxP compliance, and 21 CFR Part 11 requirements.
• Lead UAT activities, system investigations, reporting enhancements, and collaborate with PV, IT, QA, and business stakeholders.

Formação académica

Bachelor's degree

Advanced degree

Ferramentas

Oracle SQL

PL/SQL

Unix/Windows Shell

Cognos

Spotfire

SSRS

Insight

MedDRA

Pharmacovigilance reporting systems

Descrição da oferta de emprego

The Fountain Group is seeking a Pharmacovigilance Reporting & Analytics Consultant for a fully remote US role. The position focuses on supporting and enhancing PV reporting and analytics systems, including Argus Safety, with a strong emphasis on data-driven insights.

Responsibilities include gathering business requirements, designing and developing reporting solutions, and validating systems to meet 21 CFR Part 11 and GxP standards, while leading UAT and collaborating across PV, IT, QA, and