Senior PV Systems Architect: Safety Data & Compliance

MMS Holdings Inc; Chicago (IL); 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, configuration, upgrades, and E2B reporting. You will support PV systems globally and ensure alignment with regulatory standards. Experience with Axway Interchange and ARISg is a plus.

In this role you will collaborate with cross‑functional teams, drive process improvements, and develop SOPs for pharmacovigilance systems. Strong communication and problem‑solving skills are essential.

Qualifications

• College degree in IT or related field.
• Minimum of 5 years in IT or a similar field.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Good communication and problem‑solving skills.
• Familiarity with ISO 9001 and ISO 27001 standards preferred.
• 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 systems associated with PV and drug safety.
• Performs updates to Argus configuration and processes as per changing regulations.
• Provides support and execution of activities related to EudraVigilance testing for various clients.
• Performs case migration/database transfers, file importing and supports other case processing activities.
• Provides leadership in executing Argus upgrades and related activities.
• Provides administrator support for other safety databases (such as ARISg).
• Performs periodic coding dictionary updates for Argus (MedDRA & WHO drug).
• Provides technical assistance and support to Drug Safety Associate team with electronic submissions to European agencies.
• Writes SOPs and data entry manuals for Argus Safety.

Skills

Argus Safety

System architecture

PV knowledge

Communication

Problem solving

MS Office

Education

Bachelor's degree in IT or related field

Tools

MS Office

Axway Gateway Interchange

Argus Safety

Job description

MMS Holdings Inc. seeks a Senior Pharmacovigilance System Architect to lead Argus Safety administration, configuration, upgrades, and E2B reporting. You will support PV systems globally and ensure alignment with regulatory standards. Experience with Axway Interchange and ARISg is a plus.

In this role you will collaborate with cross‑functional teams, drive process improvements, and develop SOPs for pharmacovigilance systems. Strong communication and problem‑solving skills are essential.