1.Primarily focusing on project and operational routine support for Technical Software Application related to Pharma Regulatory and Pharmacovigilance.
2. Responsible for Applications like:-
RIMS (Regulatory Information Management System)
Drug Safety application : Oracle Argus,
Artwork Management System,
Learning Management System SABA .
3. Work with Business Process Owners to ensure the business requirements implementation, Application uptime, Change request are met on time.
4. Ensure user base is effectively trained and positioned to use all available system functionalities.
5. Leverage existing applications, systems and processes for increase in utilization.
6. Ensure IT activities are executed according to regulatory compliance standards. Work with Corporate QA to ensure compliance requirements are met.
7. Manage the vendors / partners / support teams; coordinate with client Subject Matter Experts (SMEs) and location IT team.
1. 7 + years of experience in supporting Pharma software related to Regulatory and Pharmacovigilance area.
2.Project Management & software Implementation experience.
3. Ability to troubleshoot various application issues related to software programming, application & web server, database, hardware and network.
4.Knowledge of Manufacturing, Quality and Regulatory processes in Pharma industry.
5.Knowledge of GXP validated environment.
6. Knowledge of software validation practices.