We are looking for an experienced Technical Support Specialist with robust expertise in pharmacovigilance (PV) systems, including Argus, Axway, Apex, BI Publisher, and related integrations. The role requires deep technical and regulatory knowledge, along with the ability to manage system configurations, customizations, and technical support activities for global ICSR submissions. The specialist will be responsible for maintaining PV system stability, ensuring compliance with worldwide regulatory standards, supporting audits, and overseeing data quality and system-related issue resolution. Our client is a global leader in the life sciences and healthcare domain. This long-term project focuses on reliable PV system operations, integration support, regulatory alignment, and continuous improvement across global safety platforms.
Location: Bangalore, India
Job Responsibilities:
1. Argus System Management
Configure Argus PLS, reporting rules, code lists, and system settings.
Manage Argus user accounts and access controls.
Oversee batch report submissions and EDQM code configurations.
Support Japan paper reporting using BI Publisher.
Perform server management and scripting for system optimization.
2. System & Gateway Support
Maintain Axway gateway connections with regulatory authorities and license partners.
Perform certificate updates and installations (monthly).
Provide Apex system support and troubleshooting.
3. Customization & Code Management
Manage custom codes and workflows for Apex ICSR quality checks.
Implement pre-save and post-save customizations.
Maintain standalone functions, trigger changes, and custom E2B profiles.
4. ICSR Submission Management
Monitor daily ICSR submissions, acknowledgements, and failures.
Resolve submission issues and perform manual submissions when required.
Analyze late submissions and liaise with CLIENT ICSR Submission team.
Communicate with regulatory authorities and assess global requirement changes.
5.
📌 7 Argus Support Engineer (Bengaluru)
🏢 Customertimes
📍 Bengaluru
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