PIM Technical Analyst

1 week ago

IND Bengaluru Technology Campus, India BD Full time
Job Description SummaryOverview: 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

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Primary Work LocationIND Bengaluru - Technology CampusAdditional LocationsWork Shift

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