Accountabilities:
- Manage implementation, upgrade, and support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrations.
- Participate in technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations.
- Act as Oracle Argus SME, supporting technical issues associated with Oracle Argus Safety suite and related interfaces.
- Deliver project and customer success by meeting deadlines, managing expectations, and delivering high-quality solutions.
- Guide the team on critical issues or enhancements.
- Participate in design, build, and configure applications, acting as the main point of contact.
Essential Skills/Experience:
- Overall IT experience of at least 10 years, with a minimum of 8 years in implementation/upgrade/support of Oracle Argus Safety.
- Prior experience in Oracle Argus managed services team and at least a couple of implementation/upgrade projects involving configuration/validation/data migration.
- Experience in configuring reporting destinations and rules with advanced conditions.
- Must have implemented continuous improvements.
- Must have trained and mentored junior members.
- Experienced in working with people from different geographies (e.g., USA, Europe).
- Experience in latest PV regulations by EMA, FDA, MHRA, and other regulatory agencies.
- Experience in PMDA regulations and working with Japan stakeholders.
- Experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP.
- Solid experience in SQL, PL/SQL.