Safety Systems Manager

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.