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

Lancesoft; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Alnylam is seeking a Consultant, Reporting and Analytics within Global Safety Systems to collaborate with SRM stakeholders and develop solutions for extracting and analyzing safety data. The role involves generating formal reports and listings to support medical monitoring, signal detection, and aggregate reporting deliverables, including PBRERs and DSURs.

The position requires experience with pharmacovigilance reporting solutions such as PV Reports, OAS/OBIEE, BIP, or Cognos, and a demonstrated

Qualifications

• Experience with pharmacovigilance reporting solutions is required, including PV Reports, OAS/OBIEE, BIP, or Cognos.
• PV Reports experience is preferred and highly advantageous.
• Role supports generation of safety data outputs and regulatory reporting requirements.

Responsibilities

• Collaborate with SRM stakeholders to develop solutions for extracting and analyzing safety data.
• Generate formal reports, summaries, and listings for medical monitoring and aggregate reporting.
• Document reporting requirements and coordinate with database service providers to fulfill requests.
• Perform quality checks on outputs to ensure alignment with requirements.
• Monitor ETL processes and scheduled report execution and address issues.
• Maintain report schedules and support validation of safety systems and reporting solutions.

Skills

Stakeholder collaboration

Reporting & analytics

Tools

PV Reports

Oracle Analytics Server (OAS)/OBIEE

BI Publisher (BIP)

Cognos

Job description

This is remote requirement If a candidate is local and prefers to work hybrid, they can Eastern or Central Time preferred. Role primarily begins on Eastern Time. Western Time Zone candidates may need to start as early as 7:00 AM to ensure sufficient overlap with Eastern Time 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 Alnylam s compliance with applicable regulatory requirements and ICH guidelines governing adverse event and product complaint reporting.