Job Title: Reporting and Analytics Consultant

Location: Hybrid in Cambridge (Preferred, 2x per week onsite) or Remote (EST only)

Working Hours: M-F 9-5, flexibility for global meetings as needed

Position Overview:

We are seeking an experienced Reporting and Analytics Consultant to join our Global Safety Systems (GSS) team. This role involves working with stakeholders to generate data and listings using reporting tools such as OBIEE, BIP, and visualizations. The consultant will support the development, validation, and analysis of new reporting while ensuring data quality and compliance with regulatory standards.

Key Responsibilities:

• Collaborate with GPSRM staff to develop solutions for extracting and analyzing safety data.
• Generate formal reports, summaries, and listings for medical monitoring, signal detection, and aggregate reporting deliverables (PBRER, DSUR) in partnership with the database service provider.
• Complete data request forms in coordination with GPSRM staff and the database service provider.
• Perform quality checks on data requests to identify and resolve discrepancies.
• Assist in qualification/validation processes of GSD applications.
• Take on additional tasks as needed to ensure compliance with regulatory agency guidelines and ICH regulations regarding adverse events and product complaints.

Qualifications:

• B.S. in Computer Science or equivalent, with at least 4 years of experience.
• Experience in Oracle Argus Safety is required; Oracle Cloud experience is preferred.
• Proficiency in reporting tools (OBIEE, Cognos, Business Objects, BIP) is essential, with a preference for OBIEE/BIP.
• Knowledge of relational databases (Oracle, SQL) is required.
• Familiarity with the Software Development Lifecycle (SDLC) and experience with qualification/validation processes.
• Knowledge of PSUR/PBRER/DSUR is preferred.
• Experience authoring validation deliverables and executing test scripts (OQs/PQs).
• At least 4 years of experience in drug safety and reporting solutions in a pharmacovigilance context.
• Experience with PV reports is a plus.