Project Role: Custom Software Engineer

Project Role Description: Design, build and configure applications to meet business process and application requirements.

Must have skills: Veeva Vault

Good to have skills: NA

Minimum 5 year(s) of experience is required

Educational Qualification: 15 years full time education

Summary:

We are seeking an experienced professional with strong expertise in Veeva Safety and Pharmacovigilance (PV) systems to join our team. The ideal candidate will have hands-on experience in business administration and configuration of Veeva Safety, along with a solid background in PV processes and other safety tools such as Oracle Argus

Roles & Responsibilities:

• Provide L2/L3 AMS support for Veeva Safety application, ensuring system stability and compliance.
• Perform business administration and configuration tasks in Veeva Safety as per client requirements.
• Troubleshoot and resolve incidents, service requests, and configuration issues.
• Collaborate with client stakeholders for change requests, enhancements, and upgrades.
• Ensure adherence to SLA and compliance standards in all support activities.
• Document solutions, SOPs, and maintain knowledge base for recurring issues.
• Support integrations between Veeva Safety and other PV tools or reporting systems.
• Work closely with cross-functional teams (IT, Quality, Regulatory) for system enhancements and troubleshooting.

Professional & Technical Skills:

• Minimum 7–8 years of experience in Pharmacovigilance systems (Veeva Safety, Oracle Argus, or similar) with 1-2 exclusive experience on Veeva Safety support or implementation
• Strong knowledge of business administration and configuration in Veeva Safety.
• Experience in AMS support model (incident management, problem management, change management).
• Understanding of PV processes and regulatory compliance (FDA, EMA, ICH).
• Familiarity with system validation and audit readiness.
• Excellent communication and client interaction skills.
• Understanding of PV processes, regulatory compliance (FDA, EMA, ICH guidelines),ICSR,E2BR3.
• Experience in system validation and change management.
• Excellent communication and stakeholder management skills.

Additional Information:

• Min 1-2 years Experience with Veeva Safety configurations and support or Implementation .
• Knowledge of PL/SQL is added benefit
• Bachelor s degree in Life Sciences, Pharmacy, Computer Science, Bachelor of Engineering related field.

15 years full time education

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