Job Description

Project Role :

Custom Software Engineer

Project Role Description :

Develop custom software solutions to design, code, and enhance components across systems or applications. Use modern frameworks and agile practices to deliver scalable, high-performing solutions tailored to specific business needs.

Must have skills :

Veeva Vault

Good to have skills :

NA

Minimum

3

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: o Provide L2/L3 AMS support for Veeva Safety application, ensuring system stability and compliance. o Perform business administration and configuration tasks in Veeva Safety as per client requirements. o Troubleshoot and resolve incidents, service requests, and configuration issues. o Collaborate with client stakeholders for change requests, enhancements, and upgrades. o Ensure adherence to SLA and compliance standards in all support activities. o Document solutions, SOPs, and maintain knowledge base for recurring issues. o Support integrations between Veeva Safety and other PV tools or reporting systems. o Work closely with cross-functional teams (IT, Quality, Regulatory) for system enhancements and troubleshooting. Professional & Technical Skills: o Minimum 5-6 years of experience in Pharmacovigilance systems (Veeva Safety, Oracle Argus, or similar) with 1-2 exclusive experience on Veeva Safety support or implementation project o Strong knowledge of business administration and configuration in Veeva Safety. o Experience in AMS support model (incident management, problem management, change management). o Understanding of PV processes and regulatory compliance (FDA, EMA, ICH). o Familiarity with system validation and audit readiness. o Excellent communication and client interaction skills. o Understanding of PV processes, regulatory compliance (FDA, EMA, ICH guidelines),ICSR,E2BR3. o Experience in system validation and change management. o Excellent communication and stakeholder management skills. Additional Information: o Min 1-2 years' Experience with Veeva Safety configurations and support or Implementation. o Knowledge of PL/SQL is added benefit o Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Bachelor of Engineering or related field.




15 years full time education