Oracle Empirica Implementation Consultant
- Zensar
- 5 - 10 years
- Pune
- 2 months ago
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Job Description
Seeking an experienced Oracle Empirica Implementation Consultants to support the implementation, customization, and optimization of Oracle Empirica a leading pharmacovigilance and signal detection solution. This role is critical to ensuring the successful deployment of Oracle Empirica within customer s operational framework, enabling enhanced safety monitoring, compliance, and decision-making capabilities.
The ideal candidate will bring deep expertise in Oracle Empirica, hands-on implementation experience, and a strong understanding of pharmacovigilance processes and regulatory requirements. It involves collaboration with cross-functional teams, including IT, and business stakeholders.
Key Responsibilities
- Implementation and Configuration : Take a leading role in the end-to-end implementation of Oracle Empirica, including system setup, configuration, and integration with existing Cencora systems.
- Requirements Gathering : Collaborate with stakeholders to understand business needs, define technical requirements, and translate them into actionable implementation plans.
- Customization : Tailor Oracle Empirica functionalities to align with customer pharmacovigilance workflows, regulatory compliance standards, and business objectives.
- Data Integration : Ensure seamless integration of Oracle Empirica with internal databases, data warehouses, and third-party systems for efficient signal detection and reporting.
- Testing and Validation : Participate in rigorous system testing, user acceptance testing (UAT), and validation to ensure the solution meets predefined requirements and performs optimally.
- Training and Support : Provide training to end-users, develop documentation, and offer ongoing technical support to ensure successful adoption and usage of Oracle Empirica.
- Compliance and Best Practices : Ensure the implementation aligns with global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines) and industry best practices.
- Project Management : contribute to the management of project timelines, deliverables, and risks, ensuring milestones are met and stakeholders are informed of progress.
- Troubleshooting : Identify and resolve technical issues during implementation and post-deployment phases.
Qualifications
Required Skills and Experience
- Proven experience in implementing Oracle Empirica, including signal detection, data mining, and adverse event reporting modules.
- Strong understanding of pharmacovigilance processes, regulatory requirements, and compliance standards (e.g., FDA, EMA, ICH).
- Expertise in system integration, including database management (e.g., Oracle, SQL), ETL processes, and API integrations.
- Hands-on experience with system testing, validation, and user acceptance testing (UAT).
- Proficiency in managing large-scale implementation projects with cross-functional teams.
- Excellent problem-solving skills and ability to troubleshoot technical issues.
Preferred Skills
- Familiarity with other Oracle Health Sciences solutions, such as Argus Safety.
- Knowledge of cloud-based deployment models and Oracle Cloud infrastructure.
- Experience in the pharmaceutical or healthcare industry is highly desirable.
- Strong communication skills to liaise effectively with technical and non-technical stakeholders.
Education and Certifications
- Bachelor s degree in Computer Science, Information Systems, Life Sciences, or a related field (Master s degree preferred).
- Oracle certifications related to Empirica or Oracle Health Sciences Suite are a plus.
- Project management certifications (e.g., PMP, Agile) are an advantage.
Qualifications
Required Skills and Experience
- Proven experience in implementing Oracle Empirica, including signal detection, data mining, and adverse event reporting modules.
- Strong understanding of pharmacovigilance processes, regulatory requirements, and compliance standards (e.g., FDA, EMA, ICH).
- Expertise in system integration, including database management (e.g., Oracle, SQL), ETL processes, and API integrations.
- Hands-on experience with system testing, validation, and user acceptance testing (UAT).
- Proficiency in managing large-scale implementation projects with cross-functional teams.
- Excellent problem-solving skills and ability to troubleshoot technical issues.
Education and Certifications - Bachelor s degree in Computer Science, Information Systems, Life Sciences, or a related field (Master s degree preferred).
- Oracle certifications related to Empirica or Oracle Health Sciences Suite are a plus.
- Project management certifications (e.g., PMP, Agile) are an advantage.
Key Responsibilities
- Implementation and Configuration : Take a leading role in the end-to-end implementation of Oracle Empirica, including system setup, configuration, and integration with existing Cencora systems.
- Requirements Gathering : Collaborate with stakeholders to understand business needs, define technical requirements, and translate them into actionable implementation plans.
- Customization : Tailor Oracle Empirica functionalities to align with customer pharmacovigilance workflows, regulatory compliance standards, and business objectives.
- Data Integration : Ensure seamless integration of Oracle Empirica with internal databases, data warehouses, and third-party systems for efficient signal detection and reporting.
- Testing and Validation : Participate in rigorous system testing, user acceptance testing (UAT), and validation to ensure the solution meets predefined requirements and performs optimally.
- Training and Support : Provide training to end-users, develop documentation, and offer ongoing technical support to ensure successful adoption and usage of Oracle Empirica.
- Compliance and Best Practices : Ensure the implementation aligns with global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines) and industry best practices.
- Project Management : contribute to the management of project timelines, deliverables, and risks, ensuring milestones are met and stakeholders are informed of progress.
- Troubleshooting : Identify and resolve technical issues during implementation and post-deployment phases.
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Engineering - Software & QARole Category: DBA / Data warehousingRole: Database AnalystEmployement Type: Full timeContact Details:
Company: ZensarLocation(s): Pune+ View Contact
Keyskills: System testing PMP Project management System integration Agile Healthcare Oracle Data mining Technical support Monitoring
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