What are the responsibilities and job description for the Reporting and Analytics Consultant - Global Safety Systems position at BioPharma Consulting JAD Group?
Consultant Reporting and Analytics Global Safety Systems (GSS) will work with different stakeholders to generate the data and listings using reporting tools like OBIEE, BIP, and visualizations. In addition, the role supports analyzing the need for new reporting and developing and validating the same.
Key Responsibilities:
- Work with GPSRM staff to create solutions for extracting and analyzing safety data. Experience in BI Publisher, Argus Analytics (OBIEE) is preferred.
- Responsible for generating formal reports, summaries, and listings supporting medical monitoring, signal detection, and aggregate reporting deliverables (PBRER, DSUR) in conjunction with the database service provider.
- Work with GPSRM staff to complete the data request forms and coordinate with the database service provider to complete requests.
- Perform quality checks on data requests generated by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution.
- Assist in the process of qualification/validation of GSD applications.
- Willing to take on additional departmental tasks, as assigned by your immediate supervisor, to ensure Alnylam’s compliance with all regulatory agency and ICH regulations and guidelines governing the reporting of adverse events and product complaints.
Qualifications
- BS Computer Science/equivalent qualification with at least 4 years of experience.
- Experience in Oracle Argus Safety is required. Additionally, work experience with Oracle Cloud is preferred.
- Experience in reporting tools (OBIEE, Cognos, Business Objects, BIP) is required. Knowledge of OBIEE/BIP is preferred.
- Relational database knowledge working with Oracle and SQL is required.
- General knowledge of the Software Development Lifecycle (SDLC) is required, and experience performing qualification/validation is required.
- Knowledge of PSUR/PBRER/DSUR is preferred.
- Experience authoring various Validation deliverables.
- Experience executing test scripts (OQs/PQs)
- Location: Hybrid in Cambridge Preferred (2X per week onsite)
- Working Hours - M-F 9-5, Flexibility to be on global meetings as needed
- Working Weekends – No
