Drug Safety Reporting & Analytics Specialist

Meet Life Sciences is recruiting for an unnamed leading biopharmaceutical company specializing in RNA interference (RNAi) therapeutics. The Drug Safety Reporting & Analytics Specialist supports Global Safety Systems through pharmacovigilance reporting, safety data analytics, report validation, and development of reporting solutions for drug safety monitoring and regulatory compliance.

Responsibilities

• Develop and generate safety data reports, listings, summaries, and visualizations to support medical monitoring, signal detection, and regulatory reporting activities
• Utilize pharmacovigilance reporting tools such as PV Reports, Oracle Analytics Server (OAS), OBIEE, BI Publisher (BIP), or Cognos
• Support aggregate safety reporting deliverables, including Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs)
• Collaborate with Safety and Risk Management stakeholders to gather reporting requirements, document specifications, and coordinate data requests
• Partner with database service providers to facilitate report generation and ensure deliverables align with documented requirements
• Perform quality checks on reports and data outputs, identify discrepancies, and coordinate resolution of issues
• Monitor ETL processes and scheduled report executions to ensure accurate and timely delivery of safety data outputs
• Create, maintain, and verify report schedules while troubleshooting reporting or system-related issues
• Support the qualification and validation of Global Safety Systems applications and reporting solutions, including report validation
• Maintain documentation and follow established procedures to support regulatory compliance and data integrity
• Collaborate with cross-functional teams to assess new reporting needs and develop, test, and implement reporting solutions
• Perform additional responsibilities as needed to support departmental objectives and applicable regulatory requirements, including ICH guidelines

Preferred

• Understanding of applicable pharmacovigilance regulations and ICH guidelines
• Pharmacovigilance Regulations
• ICH Guidelines

Company

• Life sciences talent solutions provider
• London, England, GBR
• https://www.peoplewithchemistry.com/
• Founded in 2009
• 51-200 employees

Qualifications

• experienced Drug Safety Reporting & Analytics Specialist
• The ideal candidate will have experience with pharmacovigilance reporting tools, safety data extraction, report validation, and quality assurance within a regulated pharmaceutical or biotechnology environment
• Bachelor's degree in Computer Science or a related field
• Experience with pharmacovigilance reporting solutions, such as PV Reports, Oracle Analytics Server (OAS), OBIEE, BI Publisher (BIP), or Cognos
• Experience generating, reviewing, and validating safety data reports, listings, and analytical outputs
• Understanding of pharmacovigilance and drug safety reporting processes within the pharmaceutical or biotechnology industry
• Experience documenting business and reporting requirements and coordinating data requests with internal stakeholders and external service providers
• Strong quality assurance skills, including the ability to identify data discrepancies and troubleshoot reporting issues
• Familiarity with report scheduling, ETL monitoring, and routine system monitoring activities
• Knowledge of system qualification, validation practices, and regulatory compliance requirements in a GxP-regulated environment
• Strong analytical, organizational, communication, and problem-solving skills
• Experienced Drug Safety Reporting & Analytics Specialist
• Understanding of applicable pharmacovigilance regulations and ICH guidelines

Required skills

• BI Publisher (BIP), Cognos, ETL Monitoring, GxP Compliance, ICH Guidelines, OBIEE, PBRER and DSUR Reporting, PV Reports, Pharmacovigilance Reporting

Preferred skills

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Experience

• Mid level