Consultant, Reporting and Analytics, Global Safety Systems

Planet Pharma; Cambridge (MA); On-site; USD 107,000 - 118,000; Full time

Job summary

Planet Pharma is seeking a Consultant, Reporting and Analytics within Global Safety Systems (GSS) to collaborate with SRM stakeholders. The role will generate safety data outputs, reports, listings, and visualizations using pharmacovigilance reporting tools and support new reporting needs.

The consultant will participate in development, testing, and validation of reporting solutions, monitor ETL processes, and ensure timely, compliant delivery of safety outputs.

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 preferred.
• Ability to collaborate with SRM stakeholders to define reporting requirements and translate them into data outputs.

Responsibilities

• Collaborate with Safety and Risk Management (SRM) stakeholders to develop solutions for extracting and analyzing safety data.
• Generate formal reports, summaries, and listings to support medical monitoring, signal detection, and aggregate reporting deliverables (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 documented requirements and coordinate resolution of discrepancies.
• Monitor ETL processes and scheduled report executions; coordinate issue resolution.
• Create, maintain, and verify report schedules to ensure timely delivery of outputs.
• Support qualification and validation of Global Safety Systems applications and reporting solutions.
• Perform additional department responsibilities to support regulatory compliance and ICH guidelines.

Skills

Pharmacovigilance reporting

Data analysis

Stakeholder collaboration

Tools

PV Reports

Oracle Analytics Server/OAS

OBIEE

BI Publisher

Cognos

Job description

Job Description:

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.

Pay ranges between 78-86/hr based on experience