Reporting and Analytics Consultant - Global Safety Systems

Job Description

Job Description

We are seeking a highly analytical and detail-oriented Consultant – Reporting & Analytics, Global Safety Systems (GSS) to support the development and validation of safety data reporting solutions. This role will collaborate with Global Patient Safety and Risk Management (GPSRM) staff and other stakeholders to generate reports and listings using tools such as OBIEE, BI Publisher (BIP), and other visualization/reporting tools. The consultant will help meet the increasing demand for safety-related reporting in support of signal detection, aggregate reporting (PBRER, DSUR), and regulatory compliance.

Responsibilities:

• Partner with GPSRM and database service providers to generate data extracts, formal listings, and analytics from safety systems.
• Use BI tools (e.g., OBIEE, BIP) to develop and maintain reports and visualizations to support safety monitoring and regulatory deliverables.
• Coordinate data request submissions with GPSRM and ensure accurate implementation with database service providers.
• Perform detailed quality checks on outputs and resolve discrepancies between requests and generated data.
• Assist in the qualification/validation of Global Safety Systems applications, including authoring and executing test scripts (OQs/PQs).
• Contribute to the continuous improvement of reporting processes and documentation standards.
• Support the development of new safety reporting requirements by analyzing stakeholder needs and translating them into reporting solutions.

Skills:

• Strong understanding of pharmacovigilance workflows and regulatory requirements.
• High attention to detail and ability to ensure data accuracy.
• Strong problem-solving skills and ability to work cross-functionally.
• Excellent written and verbal communication skills.
• Comfortable working in a fast-paced, deadline-driven environment.

Requirements

Education: Bachelor’s degree in Computer Science or a related field. Open to other disciplines (e.g., PharmD) with relevant data analytics and PV experience.

Experience:

• Minimum 4 years of experience in drug safety or pharmacovigilance with a focus on reporting and analytics.
• Strong experience working with Oracle Argus Safety.
• Proficiency in reporting tools, especially OBIEE and BI Publisher (BIP).
• Experience working with relational databases (Oracle, SQL).
• Familiarity with Oracle Cloud is preferred.
• Experience with PV deliverables such as PBRER, DSUR, and PSUR is highly desirable.
• Proven experience authoring and executing validation documents and test scripts in accordance with SDLC.

Benefits

• Hybrid – Cambridge, MA (2x/week onsite preferred)
• Monday–Friday, 9:00 AM–5:00 PM
• 6-months contract with possible extension