Safety Systems Manager
Location: Bay Area, California (On-site, 5 days per week)
Company: Excelexis
About the Company
Excelexis is an innovative biotechnology company dedicated to developing transformative therapies for patients with serious and unmet medical needs. With a strong scientific foundation and a growing clinical pipeline, the company fosters a collaborative and fast-paced environment focused on advancing impactful medicines.
As the organization continues to scale its pharmacovigilance infrastructure, they are seeking a Safety Systems Manager to lead the management and optimization of their drug safety systems.
This is an on-site role based in the Bay Area (5 days per week). Relocation support is available, and the position offers a very competitive compensation and benefits package.
Position Overview
The Safety Systems Manager will be responsible for the administration, configuration, and continuous improvement of pharmacovigilance systems supporting global safety operations. This individual will work closely with Pharmacovigilance, Clinical, Regulatory, Quality, and IT teams to ensure safety systems remain compliant, efficient, and scalable as the company grows.
The role will also oversee system validation, vendor management, and data governance related to safety platforms.
Key Responsibilities
- Serve as the system owner and administrator for the pharmacovigilance safety database (e.g., Argus, ArisG, or similar platforms).
- Manage system configuration, upgrades, patches, and enhancements to support global safety operations.
- Ensure compliance with regulatory requirements related to pharmacovigilance systems (FDA, EMA, ICH guidelines).
- Lead computer system validation (CSV) activities for safety systems, including documentation, testing, and change control.
- Collaborate with Pharmacovigilance teams to optimize workflows for case processing, reporting, and signal management.
- Oversee data integrity, system security, and user access management.
- Manage relationships with external vendors and system providers.
- Support aggregate reporting and regulatory submission workflows through system optimization.
- Develop and maintain SOPs, system documentation, and training materials.
- Provide training and user support to internal stakeholders on safety system functionality.
- Support regulatory inspections and internal audits related to pharmacovigilance systems.
Qualifications
- Bachelor s degree in Life Sciences, Computer Science, Information Systems, or a related field.
- 5+ years of experience in pharmacovigilance systems or safety operations, preferably within biotech or pharmaceutical companies.
- Hands-on experience with drug safety databases such as Argus Safety, ArisG, or similar PV platforms.
- Strong understanding of pharmacovigilance regulations and compliance requirements.
- Experience with computer system validation (CSV) and system lifecycle management in a regulated environment.
- Familiarity with MedDRA, E2B reporting standards, and safety data workflows.
- Strong analytical and problem-solving skills with the ability to improve operational efficiency.
- Excellent cross-functional communication and project management skills.
Why Join
- Opportunity to play a key role in building and scaling pharmacovigilance systems at a growing biotech.
- Highly competitive compensation package, including salary, bonus, and equity.
- Relocation assistance available for candidates moving to the Bay Area.
- Collaborative and mission-driven team environment focused on improving patient outcomes.
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