Job Description Summary
Overview: We are seeking a technically proficient and detail-oriented PIM Technical Analyst to support the implementation, configuration, and validation of Oracle Cloud Product Data Hub (PDH) systems. This role plays a critical part in enabling global regulatory compliance, data governance, and seamless integration across enterprise systems. The analyst will work closely with cross-functional teams to deliver high-quality solutions and support ongoing PIM initiatives.
Job Description
P4-12448
Key Responsibilities:
1. Release Planning & Technical Assessment
- Participate in PIM release planning to define and scope technical deliverables.
- Conduct technical feasibility assessments for fit-gap solution options.
- Contribute to validation strategy planning, particularly for Operational Qualification (OQ).
- Author and contribute to System Design Specifications (SDS) for PIM releases.
2. System Configuration & Enhancement
- Configure Oracle Cloud PDH environments (non-production and production).
- Enable users to maintain Global UDI attributes for markets including EU, China, South Korea, Saudi Arabia, US, Taiwan, Singapore, and Australia.
- Incorporate system review feedback to enhance application functionality.
- Enhance the Marketing Solution set to support new locales and feed BD marketing websites.
3. Cross-Functional Collaboration
- Collaborate with Regulatory Affairs, Marketing, and Environment Health & Safety (EHS) teams to align data standards and processes.
- Work with the Integration Team to design, develop, and support inbound/outbound integrations between Oracle Cloud PDH and enterprise systems.
4. Regulatory Compliance & Data Governance
- Configure and support Cloud PDH for UDI data submission to global regulatory bodies including EUDAMED and US FDA via Reed Tech.
- Establish and maintain a data governance framework in Cloud PDH, including setup of Change Orders, New Item Requests, and Item Business Rules.
5. Reporting & Visualization
- Build interactive reports and dashboards to visualize regulatory data, compliance timelines, data completeness scores, and submission readiness.
6. Validation & Testing
- Document and execute IQ test scripts; support OQ and PQ validation activities.
- Participate in system verification and validation activities across IQ, OQ, and PQ phases.
- Document System Configuration Workbook and Oracle Web Services Instructions tailored to BD’s integration needs.
7. Deployment & Support
- Support PIM cutover, deployment, and hypercare activities.
- Conduct knowledge transfer sessions and assist in post-implementation stabilization.
- Support the AMO team in resolving business-critical, time-sensitive issues.
- Assist the PIM Business team with project-related and ad hoc activities, including data migration and onboarding.
Qualifications:
- Hands-on experience with Oracle Cloud PDH and PIM systems.
- Strong understanding of global UDI requirements and life sciences regulatory frameworks.
- Proficiency in system configuration, integration design, and validation documentation.
- Excellent collaboration and communication skills across technical and business teams.
Required Skills
Microsoft SQL Server, Oracle, Oracle Management, PIM-SM, Structured Query Language (SQL), Structured Query Language (SQL) Development
Optional Skills
Data Governance, Document Validation, Validation Testing
.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift