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Connexion Systems & Engineering, Inc Logo Connexion Systems & Engineering, Inc · -

Drug Safety Analyst

United States, Los Angeles Contract work 42.00 - 45.70 USD / Hour · Job Posted March 22, 2026
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Job Description

We are seeking a Drug Safety Analyst to support global pharmacovigilance operations for both investigational and marketed products. This role plays a critical part in ensuring high-quality safety data, regulatory compliance, and timely reporting. This position is ideal for candidates with strong experience in safety data analysis, pharmacovigilance systems, and database reporting, particularly those who have worked with safety databases and reporting tools in regulated environments.

Job Responsibility

  • Analyze and process safety data to support aggregate reports and regulatory submissions
  • Develop and execute data extraction queries for pharmacovigilance documentation
  • Perform database queries to identify interval and cumulative cases for periodic reports
  • Generate case listings for regulatory and business needs
  • Support signal detection and signal management activities
  • Maintain data consistency and integrity within the global safety database
  • Support database configuration updates, including: Regulatory submission rules
  • Product and study configurations
  • Partner with IT to support system validation, testing, and enhancements
  • Contribute to continuous system improvements and process optimization
  • Ensure compliance with global pharmacovigilance regulations and reporting timelines
  • Support audits, inspections, and CAPA activities
  • Collaborate with Regulatory Affairs on aggregate safety reporting requirements
  • Maintain and support PV documentation (SOPs, WPs, specifications, process flows)
  • Review scientific literature and support medical safety assessments
  • Develop training materials and support internal knowledge sharing
  • Assist with change management and implementation of new systems/processes

Requirements

  • Bachelor’s degree in Health Sciences, Life Sciences, or Information Technology
  • 2+ years of pharmacovigilance experience
  • 2+ years of safety database or data management experience
  • Strong experience with safety data analysis and reporting tools (Business Objects strongly preferred)
  • Hands-on experience with: Data extraction queries and reporting
  • Database querying for safety case analysis
  • Ensuring data integrity within safety systems
  • Experience supporting database configuration updates tied to regulatory submissions
  • Proficiency in Microsoft Office (Excel, PowerPoint, Visio, Word)
  • Experience in GMP environments and/or computer system validation (CSV) (essential)
  • Knowledge of E2B (R2) and E2B (R3) standards (preferred)
  • Familiarity with: MedDRA
  • WHO Drug Dictionary
  • Medical terminology
  • Strong analytical and problem-solving skills
  • Ability to work independently and manage multiple priorities
  • Detail-oriented with a focus on data accuracy and compliance
  • Effective communicator with cross-functional collaboration experience

Nice to have

Knowledge of E2B (R2) and E2B (R3) standards

What we offer

  • Flexible work arrangement (hybrid/remote potential)
  • Long-term contract with competitive pay
  • Opportunity to support global pharmacovigilance initiatives
  • High-impact role focused on data integrity, compliance, and patient safety
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