Custom Software Engineer

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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