Pharmacovigilance Reporting & Analytics Consultant

Virtual Company; Cambridge (MA); Remoto; USD 96.000 - 132.000; Tempo pieno

Vantaggi offerti da questo lavoro

Referral Bonus

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Formazione

Bachelor's degree

Advanced degree

Strumenti

Oracle SQL

PL/SQL

Unix/Windows Shell

Cognos

Spotfire

SSRS

Insight

MedDRA

Pharmacovigilance reporting systems

Descrizione del lavoro

We are a national staffing firm and are currently seeking a Pharmacovigilance Reporting & Analytics Consultantfor a prominent client of ours. This position is Fully Remote in the USA.Details of the position are as follows:

Job Details

• Pay: $70-$96/hr. to Start!!
• 6 months contract, possibility for extension based on performance and budget.
• Position will be mainly responsible for supporting and enhancing Global Pharmacovigilance (PV) reporting and analytics systems, including Argus Safety reporting solutions.
• Position will also be responsible for gathering business requirements, designing and developing reporting solutions, and supporting end-user reporting needs.
• Position will develop, maintain, and optimize database reporting solutions using Oracle SQL, PL/SQL, and related technologies.
• Position will support validation activities, GxP compliance, 21 CFR Part 11 requirements, and audit/inspection readiness.
• Position will lead UAT activities, system investigations, reporting enhancements, and collaborate with Global PV, IT, QA, and business stakeholders.

Qualifications

• Bachelor's degree is Required!
• 5-8 years of technical systems experience in Database Reporting, Business Intelligence, Data Warehousing, or related areas is Required!
• Experience supporting Pharmacovigilance Drug Safety Systems (Argus Safety preferred) and related reporting platforms 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!

Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.