Medical Affairs/Safety - Consultant Reporting and Analytics, Global Safety Systems

The Consultant, Reporting and Analytics within Global Safety Systems (GSS), will collaborate with stakeholders to generate safety data outputs, reports, listings, and visualizations using pharmacovigilance reporting tools. Experience with pharmacovigilance reporting solutions such as PV Reports, Oracle Analytics Server (OAS)/OBIEE, BI Publisher (BIP), or Cognos is required; experience with PV Reports is preferred.

Consultant Reporting and Analytics, Global Safety Systems
Cambridge, MA/REMOTE
12 Months

Overview:
The Consultant, Reporting and Analytics within Global Safety Systems (GSS), will collaborate with stakeholders to generate safety data outputs, reports, listings, and visualizations using pharmacovigilance reporting tools. The role will also support the assessment of new reporting needs and the development, testing, and validation of reporting solutions.
Summary of Key Responsibilities:

• Collaborate with Safety and Risk Management (SRM) stakeholders to develop solutions for extracting and analyzing safety data. Experience with pharmacovigilance reporting solutions such as PV Reports, Oracle Analytics Server (OAS)/OBIEE, BI Publisher (BIP), or Cognos is required; experience with PV Reports is preferred.
• Generate formal reports, summaries, and listings to support medical monitoring, signal detection, and aggregate reporting deliverables, including PBRERs and DSURs.
• Work with SRM stakeholders to document reporting requirements, complete data request forms, and coordinate with the database service provider to fulfill requests.
• Perform quality checks on outputs generated by the database service provider to confirm alignment with documented requirements. Identify discrepancies and coordinate their resolution.
• Perform routine system monitoring activities, including monitoring ETL processes and scheduled report execution, and coordinate the resolution of identified issues.
• Create, maintain, and verify report schedules to support timely delivery of reporting outputs.
• Support the qualification and validation of Global Safety Systems applications and reporting solutions (including validation of reports).
• Perform additional departmental responsibilities assigned by the immediate supervisor to support Client's compliance with applicable regulatory requirements and ICH guidelines governing adverse event and product complaint reporting.

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