The Role
The Safety Database Administrator manages safety database systems for pharmacovigilance, ensuring data integrity, compliance, and user support while generating reports for oversight.
Summary Generated by Built In
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.
Key Responsibilities
Key Responsibilities
- PV Database Management & Configuration
Maintain and configure safety databases (e.g., ArisG, Argus, or similar) to support case processing, reporting, and compliance. - Data Integrity & Compliance
Ensure accuracy, completeness (experience with UAT testing), and regulatory compliance of safety data in accordance with global PV regulations (FDA, EMA, ICH, etc.). - System Integration & Automation
Support integration of the safety database with other systems (e.g., E2B gateways, regulatory submission platforms, signal detection tools) and drive automation initiatives. - User Support & Training
Provide technical support and training to PV users, troubleshoot issues, and manage user access and roles. - Reporting & Analytics
Generate and validate safety reports, metrics, and dashboards to support PV oversight and decision-making.
Qualifications
- 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
Top Skills
Argus
Arisg
Data Visualization Tools
Excel
SQL
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The Company
What We Do
Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.
