Senior Pharmacovigilance System Architect (Argus Administrator)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Pharmacovigilance System Architect (Argus Administrator) based in India.

This role offers the opportunity to become a key technical expert supporting global pharmacovigilance and drug safety operations. You will be responsible for managing, configuring, and optimizing critical safety systems that support regulatory compliance and efficient clinical data processes. Working closely with cross-functional teams and clients, you will provide technical leadership across Argus Safety administration, upgrades, integrations, and system improvements. The position combines technical expertise, regulatory knowledge, and client collaboration in a global clinical research environment. You will help ensure reliable safety data management while contributing to process enhancements and innovative solutions. This is an opportunity for an experienced professional to make a direct impact on patient safety and pharmaceutical development.

Accountabilities:: The Senior Pharmacovigilance System Architect will serve as a subject matter expert for Argus Safety and related drug safety platforms, ensuring system reliability, compliance, and continuous improvement across pharmacovigilance operations.

Manage Argus Safety administration, including database configuration, maintenance, governance, troubleshooting, and daily technical support.

Perform Argus installations, upgrades, configuration updates, reporting rule setups, and E2B reporting integrations through gateway technologies.

Configure and maintain Axway Gateway Interchange and other systems supporting pharmacovigilance and drug safety processes.

Support regulatory updates, including EudraVigilance requirements, testing activities, and compliance-driven system changes.

Lead Argus upgrades, migrations, database transfers, file imports, and related case processing activities.

Provide administrator support for additional safety databases and pharmacovigilance platforms.

Perform coding dictionary updates, including MedDRA and WHO Drug dictionary maintenance.

Support electronic submissions of serious adverse events to regulatory authorities.

Develop and maintain technical documentation, including Standard Operating Procedures (SOPs), work practice documents, and data entry manuals.

Generate case processing metrics, identify improvement opportunities, and support implementation of process enhancements.

Partner directly with clients as a pharmacovigilance systems subject matter expert, supporting project delivery and technical discussions.

Contribute to business development activities and capability-building initiatives when required.

Maintain expertise in regulatory requirements, clinical trial processes, and industry best practices.

Requirements:

The ideal candidate is an experienced pharmacovigilance technology professional with strong Argus Safety expertise, regulatory knowledge, and the ability to collaborate effectively with global teams and clients.

Bachelor’s degree in Information Technology, Computer Science, or a related discipline, or equivalent professional experience.

5+ years of experience in Information Technology, pharmacovigilance systems, or a related technical field.

Strong hands-on experience with Argus Safety configuration, administration, and study setup.

Deep understanding of global case processing workflows and serious adverse event (SAE) reporting.

Experience supporting clinical trial development processes and pharmaceutical data environments.

Knowledge of E2B reporting, EudraVigilance requirements, and regulatory submission processes.

Experience with system upgrades, migrations, integrations, and database management.

Strong understanding of scientific concepts, clinical terminology, and drug development processes.

Familiarity with safety databases such as ARISg is desirable.

Knowledge of compliance standards including ISO 9001, ISO 27001, 21 CFR Part 11, FDA regulations, and GCP requirements is preferred.

Proficiency with Microsoft Office applications.

Excellent analytical, troubleshooting, and problem-solving skills.

Strong organizational skills with the ability to manage multiple priorities.

Excellent written and verbal communication skills with the ability to collaborate with clients and cross-functional teams.

Ability to work independently while contributing effectively within a global team environment.

Benefits:

Opportunity to work in a global clinical research and pharmaceutical technology environment.

Remote work flexibility.

Exposure to international projects and collaboration with global clients.

Opportunity to contribute to innovative pharmacovigilance and drug safety solutions.

Professional growth opportunities through technical leadership and specialized expertise development.

Collaborative and inclusive work culture focused on continuous improvement.

Competitive compensation package.

Access to company-supported learning and development opportunities.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1