Lead Pharmacovigilance Systems Architect

MMS Holdings Inc; Canton Charter Township (MI); On-site; USD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc. is seeking a Senior Pharmacovigilance System Architect to manage Argus Safety and related PV systems. This role focuses on database administration, configuration, upgrades, and compliance with global regulatory standards.

Responsibilities include E2B reporting setup, EudraVigilance, and leadership in Argus deployments, while coordinating with clients and PV teams to ensure high-quality safety data processing.

Qualifications

• College graduate in Information Technology or related field, or equivalent experience.
• Minimum 5 years’ IT experience.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader with sustained performance.
• 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, 21 CFR Part 11, FDA, and GCP requirements.

Responsibilities

• Serves as Database Administrator for Argus Safety, including database configuration and daily support.
• Performs installations, upgrades, and configuration of reporting rules and E2B via gateway technologies.
• Supports systems associated with PV and drug safety.
• Updates Argus configuration and processes per EudraVigilance regulations.
• Supports EudraVigilance testing for clients.
• Performs case migration, file importing, and other case processing activities.
• Leads Argus upgrades and related activities.
• Provides admin support for other safety databases (e.g., ARISg).
• Writes SOPs and Data Entry Manuals for Argus Safety.
• Generates metrics and drives process improvements.
• Maintains regulatory knowledge alignment with company practices.
• Interacts with clients and serves PV/drug safety systems SME.
• Strong understanding of Argus configuration and global SAE reporting.
• Understanding of global clinical trial development and data.

Skills

Argus Safety

Database Administration

Regulatory knowledge

Client communication

Leadership

Education

Information Technology degree or related field

Tools

Axway Gateway Interchange

Argus Safety

ARISg

MedDRA

WHO Drug

Job description

MMS Holdings Inc. is seeking a Senior Pharmacovigilance System Architect to manage Argus Safety and related PV systems. This role focuses on database administration, configuration, upgrades, and compliance with global regulatory standards.

Responsibilities include E2B reporting setup, EudraVigilance, and leadership in Argus deployments, while coordinating with clients and PV teams to ensure high-quality safety data processing.