Senior PV Systems Architect & Safety Tech Leader

MMS Holdings Inc; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc. seeks a Senior Pharmacovigilance System Architect to lead Argus Safety administration, upgrades, and governance. You will configure reporting rules, manage E2B submissions, and ensure regulatory alignment across PV systems and tools.

Ideal candidates have 5+ years in IT or PV tech, strong problem-solving and communication skills, and experience with ISO standards and CFR 21 Part 11. On-site role with opportunities to influence safety data workflows.

Qualifications

• Bachelor's degree in Information Technology or related field.
• Minimum of 5 years’ experience in IT or similar field.
• Excellent problem-solving skills and strong communication abilities.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsibilities

• Serves as Database Administrator for Argus Safety, including database configuration, issue resolution, maintenance, governance and daily support.
• Performs installations, upgrades, configuration of reporting rules, and E2B reporting via gateway technologies (Axway Gateway Interchange).
• Provides support for all PV and drug safety systems.
• Performs updates to Argus configuration per changing regulations.
• Leads Argus upgrades and supports related activities.
• Writes SOPs and data entry manuals for Argus Safety.
• Generates case processing metrics and supports process improvements.

Skills

Communication skills

Problem-solving

Organizational skills

Team collaboration

Regulatory knowledge

Education

Bachelor's degree in IT or related field

Tools

Argus Safety

Axway Gateway Interchange

ARISg

Job description

MMS Holdings Inc. seeks a Senior Pharmacovigilance System Architect to lead Argus Safety administration, upgrades, and governance. You will configure reporting rules, manage E2B submissions, and ensure regulatory alignment across PV systems and tools.

Ideal candidates have 5+ years in IT or PV tech, strong problem-solving and communication skills, and experience with ISO standards and CFR 21 Part 11. On-site role with opportunities to influence safety data workflows.