Drug Safety Reporting & Analytics Specialist

Meet Life Sciences; United States; On-site; USD 92,000 - 148,000; Part time

Job summary

Meet Life Sciences Ltd. is seeking an experienced Drug Safety Reporting & Analytics Specialist to support Global Safety Systems on a 12-month contract.

The role focuses on pharmacovigilance reporting, safety data analytics, and solution development to ensure drug safety monitoring and regulatory compliance. The ideal candidate will have hands-on experience with PV reporting tools, data extraction, report validation, and QA in a regulated pharma/biotech setting.

Qualifications

• Bachelor's degree in Computer Science or related field.
• Experience with pharmacovigilance reporting solutions such as PV Reports and BI tools.
• Experience generating, reviewing, and validating safety reports and analytics outputs.
• Knowledge of pharmacovigilance and drug safety reporting in pharma/biotech.
• Experience documenting requirements and coordinating data requests with stakeholders.
• Strong QA skills to identify data discrepancies and troubleshoot issues.
• Familiarity with report scheduling, ETL monitoring, and system monitoring.
• Knowledge of system qualification, validation, and regulatory compliance in GxP.
• Understanding of pharmacovigilance regulations and ICH guidelines is preferred.

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 PBRERs and 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.

Skills

Pharmacovigilance reporting

Data analysis

Report validation

Regulatory compliance

Stakeholder coordination

Quality assurance

ETL monitoring

Education

Bachelor's degree in Computer Science or related field

Tools

PV Reports

Oracle Analytics Server

OBIEE

BI Publisher

Cognos

Job description

Seeking an experienced Drug Safety Reporting & Analytics Specialist to support Global Safety Systems within a leading biopharmaceutical company specializing in RNA interference (RNAi) therapeutics. This is a 12-month contract opportunity focused on pharmacovigilance reporting, safety data analytics, and reporting solution development to support drug safety monitoring and regulatory compliance. 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.

Key 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.

Required Skills

• 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.
• Understanding of applicable pharmacovigilance regulations and ICH guidelines is preferred.Strong analytical, organizational, communication, and problem-solving skills.