Cornelia Selvaraj

Work Experience:

• Working as an Argus Safety support for a major Pharma client.
• Proven deligent working cross teams/disciplines; Outstanding interpersonal, & team building skills; Demonstrates an ability to analyze issues, on-time project delivery, trustworthy, ethical and discreet.
• Managing Support, Implementation and Maintenance of Oracle Argus Safety suite (8.x).
• Have a valuable insight on Argus Business configuration, Access Management, Axway configuration, Report distribution to Health Authorities & License Partners.

Technical Experience:

• Argus Configuration & functionality:

1.Experienced Business configuration - Products & Licenses, Clinical Studies, Expedited Report Rules.

2.Experienced in Code List, Flexible Data Re-Categorization configurations, Field Validation, Field Properties, SMTP, System Management (Common Profile Switch), Workflow.

3.Developed AC based on the requirements to Reporting Rules, Field Validation or Custom validations.

4.Good knowledge in E2B Interchange Mapping (export & import).

• Axway B2Bi Configuration:

1. Managed end-to-end Partner gateway setup.

2. Valuable insight on Community yearly certificate updates.

3. Gateway parameter updates that includes Certificates (SSL, Encryption & Signing, AWS certificates), AS2 URL, Routing ID etc.

4. System management, Application delivery, Application pickup, Collaboration settings addition & updates.

• Firewall updates: Supported firewall updates requested by Partners and ensuring successful traffic. Attained knowledge in troubleshooting firewall issue & fix.
• PV SMT(Signal & Reports): Trained in User Management and ETL monitoring.
• Right Fax: Trained in User Management.
• QALM Application Lifecycle Management: Executed IQ and OQ scripts for Argus & Axway changes.
• Toad for Oracle: Good knowledge on backend tables and productively used for analysis and retrieving expected details.

Incident & Resolution Experience:

• Experienced in handling live customer support requests and incidents with success rate of 90% getting it closed 'first time correct'.
• Effective monitoring initiated that helped in reduction of around 99% of late submissions, deviations and early catch of issues.
• Useful insights on Negative acknowledgments, Report generation errors, Validation checks and corrective actions.
• Hands on work experience in ACK issues. Contacting different Partner for missing acknowledgment, negative acknowledgment, failures etc
• Handling E2B import and LAM import issues.
• Monitoring & debugging Argus & Axway failures/issues from UI and backend.
• Replicating issue and identifying solutions.
• Handling scheduled and unexpected gateway outages with best effort on timely submissions.
• Collaborating with Database, Server, Firewall, SMTP teams to identify and resolve failures/slowness.
• Working closely with Oracle and Axway Support in investigating and fixing the issues.
• Working directly with Client on gathering requirements, demonstrations, for support on the process, issue analysis and feedback.

Testing & Documentation:

• Experienced in Reporting rule testing, E2B customizations testing.
• Experienced in gateway connectivity test with Partners.
• Design and execution of IQ and OQ scripts with datasheets or test scenarios.
• Maintained comprehensive documentation of development work, facilitating knowledge sharing among team members.
• Coordinated with other engineers to evaluate and improve software and hardware interfaces.
• Preparation of training materials and trackers for internal & client use.

Implementations & Upgrades:

• Contributed in Argus 8.1.2, 8.2 and 8.3 upgrades (Web Server, Database Server, Transaction Server).
• Worked on Axway B2Bi SP 2.6 upgrades (Axway Server, DMZ Server).
• Experience in MedDra upgrade activities.
• Implementation of NMPA localization (Shanghai & Guangdong).
• PMDA gateway updates.
• EMA requirement on 3rd row event assessment with WHO-UMC causality.

Other Skills:

• Trained & mentored junior members with concepts of Argus and Axway.
• Valuable insight on client polices and deliverables
• Leading Client and internal meetings.
• Organize channels with client and fellow teams for easier communication and support which have helped in breaking communication gaps.
• Contributing in organizing team events and outings enhancing team productivity.