Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Reporting and Analytics Consultant - Global Safety Systems
Posted: 04/11/2025
2025-04-11
2025-05-20
Employment Type:
Contract
Job Category: Pharmacovigilance
Job Number: 618761
Is job remote?: Yes
Country: United States
Job Description
Overview:
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.
Summary of 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 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)
Pay ranges between $80-87/hr based on experience
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.
Summary of 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 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)
Pay ranges between $80-87/hr based on experience
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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
