Project Description:

We are looking for an experienced Technical Support Specialist with strong 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. Regulatory & Compliance Activities

- Review new regulatory requirements and create action plans.
- Manage worldwide E2B requirements and GDPR/PIA assessments.
- Prepare QPPV reports and review PSMF quarterly.
- Support audits and inspections (up to 5/year), including CAPA management.

6. Data & System Integration

- Reconcile data between Veeva RIMS and CTMS (biannual).
- Analyze impact of support changes on integrated systems (AE intake, PVR, PVC, HaloPV).
- Support end-to-end testing for process interfaces (e.g., Rave Safety Gateway).

7. Documentation & Reporting

- Maintain system-related documentation and summary reports.
- Conduct annual user access reviews and worldwide ICSR reporting requirement reviews.
- Review product registrations and combination products periodically.

8. Inbox Monitoring

- Monitor Waves and Waves Japan inboxes (requires local language expertise).

9. Governance & Testing

- Manage change control meetings with stakeholders.
- Execute IT and business audit trail testing.
- Perform annual disaster recovery, backup/restore, and business continuity testing.

10. Data Quality & Corrections

- Conduct data analysis and corrections (2
- per year).
- Manage submission corrections (approx. 5 per year).

Requirements:

- Experience: 5-8 years in PV systems technical support and configuration.
- Technical Expertise: Argus Safety, Axway Gateway, Apex, BI Publisher, CodeBeamer.
- Solid knowledge of regulatory requirements (E2B, GDPR, PIA).
- Proficiency in scripting and server management.
- Excellent problem-solving and workflow optimization skills.
- Ability to manage audits, inspections, and compliance documentation.
- Familiarity with global pharmacovigilance processes and ICSR submissions.

📌 7 Argus Support Engineer (India)
🏢 Customertimes
📍 India