Senior Pharmacovigilance System Architect (Argus Administrator) - US

MMS Holdings Inc; Raleigh (NC); 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 E2B reporting configuration. You will ensure compliance with global regulatory requirements and support PV systems across client projects.

The role requires strong communication skills, leadership in system upgrades, and hands-on experience with Argus and related safety databases. On-site work in Raleigh, NC is expected.

Qualifications

• College degree in Information Technology or related field.
• Minimum of 5 years in IT or a similar field.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader with sustained performance.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication and problem-solving skills.
• 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: 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 PV and drug safety systems.
• Updates Argus configuration for EudraVigilance regulations.
• Supports EudraVigilance testing for clients.
• Performs case migration/database transfers and data import.
• Leads Argus upgrades and related activities.
• Administers safety databases (e.g., ARISg).
• Updates coding dictionaries (MedDRA & WHO) for Argus.
• Assists with electronic submissions to European agencies.
• Writes SOPs, Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generates case processing metrics and supports process improvements.

Skills

Argus Safety

PV systems

Leadership

Communication

Problem solving

ISO 9001

ISO 27001

FDA 21 CFR Part 11

GCP compliance

Education

College degree in IT or related field

Tools

Axway Gateway Interchange

MS Office

ARISg

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.