Senior Pharmacovigilance Systems Architect — Argus & E2B Lead

MMS; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

MMS is seeking a skilled Database Administrator with Argus Safety expertise to support PV and drug safety systems globally. You will configure, upgrade, and maintain Argus setups, support E2B submissions, and ensure compliance with IV regulatory standards.

You will also contribute to process improvements, create SOPs, and collaborate with clients as PV/drug safety SME to deliver high-quality regulatory submissions across multiple regions.

Qualifications

• College graduate in Information Technology or related field.
• Minimum 5 years’ experience in Information Technology.
• 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.
• Basic understanding of CROs and drug development processes.

Responsibilities

• DBA for Argus Safety: configuration, issue resolution, maintenance, governance, and daily support.
• Installations, upgrades, configuration of reporting rules, and E2B via Axway Gateway Interchange setup.
• Provide support for all systems associated with PV and drug safety.
• Update Argus configuration per changing EudraVigilance regulations.
• Support EudraVigilance testing for various clients.
• Perform case migrations/databse transfers and related processing.
• Lead Argus upgrades and related activities.
• Provide admin support for other safety databases such as ARISg.
• Update MedDRA & WHO dictionaries for Argus.
• Assist PV team with electronic submissions to European agencies.
• Write SOPs, Work Practice Documents, and Data Entry Manuals for Argus Safety.
• Generate case processing metrics and support process improvements.
• Maintain regulatory knowledge aligned with company practices.
• Assist business development and capabilities efforts as needed.
• Coordinate with clients; PV/drug safety SME for projects.
• Strong Argus configuration and study setup knowledge.
• Understanding of global case processing and SAE reporting.
• Understanding of global clinical trial development and data.

Skills

Argus Safety

Database admin

Eudravigilance

SOP writing

Education

IT degree

Tools

Argus Safety

Axway Gateway Interchange

ARISg

Job description

MMS is seeking a skilled Database Administrator with Argus Safety expertise to support PV and drug safety systems globally. You will configure, upgrade, and maintain Argus setups, support E2B submissions, and ensure compliance with IV regulatory standards.

You will also contribute to process improvements, create SOPs, and collaborate with clients as PV/drug safety SME to deliver high-quality regulatory submissions across multiple regions.