Senior PV Systems Architect — Argus SME

MMS; Chicago (IL); On-site; USD 130,000 - 190,000; Full time

Job summary

MMS is recruiting a Pharmacovigilance System Architect (Argus Administrator SME) to join our US team. The role focuses on Argus Safety administration, governance, and PV system support for regulatory submissions.

Ideal candidates have 5+ years in IT, strong communication skills, and experience with clinical trial data and FDA/GCP standards. This position requires collaboration with clients in a fast-paced, global CRO environment.

Qualifications

• College graduate in Information Technology or related field, or equivalent experience.
• Minimum 5 years in IT or similar field.
• Knowledge of ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Serves as Argus Safety Database Administrator for configuration, governance and daily support.
• Performs installations, upgrades, and configuration of reporting rules and E2B submissions via gateway technologies.
• Provides support for PV and drug safety systems and regulatory compliance.
• Updates Argus configurations per evolving EudraVigilance requirements.
• Leads Argus upgrades and related activities; supports other safety databases like ARISg.
• Writes SOPs and data entry manuals for Argus Safety and related systems.
• Generates metrics, reviews processes, and supports continuous improvement.

Skills

Communication skills

Problem-solving

Leadership

Teamwork

Education

Bachelor's degree in Information Technology or related field

Tools

Argus Safety

Axway Gateway Interchange

MS Office

Job description

MMS is recruiting a Pharmacovigilance System Architect (Argus Administrator SME) to join our US team. The role focuses on Argus Safety administration, governance, and PV system support for regulatory submissions.

Ideal candidates have 5+ years in IT, strong communication skills, and experience with clinical trial data and FDA/GCP standards. This position requires collaboration with clients in a fast-paced, global CRO environment.