Consultant Reporting and Analytics, Global Safety Systems

Lancesoft; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Lancesoft is seeking a Consultant, Reporting and Analytics within Global Safety Systems to collaborate with stakeholders to generate safety data outputs, reports, listings, and visualizations using pharmacovigilance reporting tools.

The role will support the assessment of new reporting needs and the development, testing, and validation of reporting solutions, including PV Reports, Oracle Analytics Server (OAS)/OBIEE, BI Publisher (BIP), or Cognos, with focus on quality checks and timely delivery.

Qualifications

• Experience with pharmacovigilance reporting solutions such as PV Reports, Oracle Analytics Server (OAS)/OBIEE, BI Publisher (BIP), or Cognos is required; PV Reports experience is preferred.
• Strong reporting and analytics experience within safety/pharmacovigilance systems is required.

Responsibilities

• Collaborate with SRM stakeholders to develop solutions for extracting and analyzing safety data using PV reporting tools.
• Generate formal reports, summaries, and listings to support medical monitoring, signal detection, and aggregate reporting deliverables (e.g., PBRERs, DSURs).
• Document reporting requirements, complete data request forms, and coordinate with the database service provider to fulfill requests.
• Perform quality checks on outputs to ensure alignment with requirements and coordinate issue resolution.
• Monitor ETL processes and scheduled report execution, and coordinate resolution of identified issues.
• Create, maintain, and verify report schedules to ensure timely delivery of outputs.
• Support qualification and validation of Global Safety Systems applications and reporting solutions, including report validation.
• Fulfill additional departmental responsibilities to comply with regulatory requirements and ICH guidelines.

Skills

Reporting experience

Analytics experience

Pharmacovigilance systems

Tools

PV Reports

Oracle Analytics Server (OAS)/OBIEE

BI Publisher (BIP)

Cognos

Job description

• Experience with the new reporting application/system referenced in the job description, which was implemented this year.
• Experience with reporting within pharmacovigilance.
• Strong reporting and analytics experience, particularly within safety/pharmacovigilance systems.

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 compliance with applicable regulatory requirements and ICH guidelines governing adverse event and product complaint reporting.