Pharmacovigilance Systems Database Administrator

SystImmune-posted 3 months ago
Mid Level
Princeton, NJ
11-50 employees
Chemical Manufacturing
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We are seeking a technically proficient and detail-oriented Safety Database Administrator to support our global pharmacovigilance (PV) operations. This role is critical to ensuring the integrity, security, and regulatory compliance of safety data related to our products. The successful candidate will work closely with the Senior Director of PV Operations and cross-functional teams to manage and optimize our safety database systems.

  • Maintain and configure safety databases (e.g., ArisG, Argus, or similar) to support case processing, reporting, and compliance.
  • Ensure accuracy, completeness (experience with UAT testing), and regulatory compliance of safety data in accordance with global PV regulations (FDA, EMA, ICH, etc.).
  • Support integration of the safety database with other systems (e.g., E2B gateways, regulatory submission platforms, signal detection tools) and drive automation initiatives.
  • Provide technical support and training to PV users, troubleshoot issues, and manage user access and roles.
  • Generate and validate safety reports, metrics, and dashboards to support PV oversight and decision-making.
  • Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.
  • 3+ years of experience in safety database administration within a pharmacovigilance or drug safety environment.
  • Hands-on experience with ArisG, Argus, or similar safety database platforms.
  • Strong understanding of global PV regulations and compliance requirements.
  • Excellent analytical, problem-solving, and communication skills.
  • Experience with system validation, audit readiness, and documentation best practices.
  • Experience with database upgrades, migrations, and enterprise-level configurations.
  • Familiarity with signal detection, risk management, and regulatory reporting tools.
  • Knowledge of SQL, EXCEL, data visualization tools, and PV analytics platforms.
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