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 time