Senior Pharmacovigilance System Architect (Argus Administrator) - US

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

Senior Pharmacovigilance System Architect

Roles & 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 (including set-up and configuration of Axway Gateway Interchange).
• Provides support for all systems associated with PV and drug safety.
• Performs updates to Argus configuration and processes as per changing EudraVigilance regulations.
• Provides support and execution of activities related to EudraVigilancetesting 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 (MedDRA & WHO drug) updates for Argus.
• Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies.
• Writes procedural documents including Standard Operating Procedures (SOP), Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generates case processing metrics, reviews and makes suggestions and supports process improvement implementation.
• Maintains technical expertise of regulatory requirements and ensures alignment with company working practices.
• Assists with business development and capabilities efforts as needed.
• Interacts directly and independently with client to coordinate all facets of projects; competent communicator, supports client capabilities as PV/drug safety systems SME.
• Strong understanding and experience working with Argus configuration and study set up.
• Strong understanding of global case processing and SAE reporting.
• Strong understanding of global clinical trial development and data.

Requirements

• College graduate Information Technology discipline or related field, or relevant experience.
• Minimum of 5 years’ experience in Information Technology or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.