Job Description
THE POSITION:
Technical Consultant plays a crucial role in pharmacovigilance, particularly in the context of the Argus Safety System. The responsibilities of an Argus administrator, as outlined, involve various aspects of configuration, data management, automation, and collaboration with case processing teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
Key Responsibilities:
- Configure, maintain, and optimize Oracle Argus Safety to support pharmacovigilance operations and regulatory reporting requirements.
- Analyze business requirements and implement Argus configurations aligned with regulatory standards and industry best practices.
- Design, develop, and enhance Argus workflows, business rules, and automation solutions to improve operational efficiency.
- Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation activities.
- Collaborate with business, safety, and technical teams to define migration requirements and source-to-target mapping specifications.
- Perform data extraction, transformation, validation, and reconciliation activities to ensure accurate and compliant migration of safety data into Argus Safety.
- Develop and execute SQL queries for data analysis, reporting, migration validation, and issue investigation.
- Identify and resolve application, configuration, integration, and data-related issues within the Argus Safety environment.
- Support system integrations between Argus Safety and external applications using web services and related technologies.
- Develop, customize, and maintain reports and dashboards using Oracle BI Publisher (BIP) to support operational and regulatory reporting needs.
- Participate in testing activities, including system integration testing (SIT), user acceptance testing (UAT), and migration validation testing.
- Ensure system configurations, migrated data, and business processes comply with global pharmacovigilance regulations, including FDA, EMA, and other applicable requirements.
- Support validation documentation and compliance activities for audits, inspections, system upgrades, and regulatory reviews.
- Collaborate with Oracle Support and internal stakeholders for incident management, patch deployments, and system enhancements.
- Provide end-user support, training, and documentation to promote effective system utilization and knowledge sharing.
- Monitor regulatory updates, Argus product enhancements, and industry trends to recommend continuous process and system improvements.
- Perform other duties and responsibilities as assigned.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Qualifications
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- Participate in end-to-end pharmacovigilance data migration projects, including data assessment, profiling, mapping, transformation, validation, and reconciliation activities.
- Collaborate with business stakeholders, Pharmacovigilance, Regulatory Affairs, and IT teams to gather migration and reporting requirements.
- Develop and maintain source-to-target mapping documents, data migration specifications, and reconciliation reports.
- Execute data extraction, transformation, cleansing, and validation activities to ensure data quality and integrity throughout the migration lifecycle.
- Perform SQL-based data analysis, data validation, reconciliation, and issue investigation to support migration and reporting activities.
- Identify, analyze, and resolve data discrepancies, mapping issues, and migration defects.
- Support migration testing activities, including System Integration Testing (SIT), User Acceptance Testing (UAT), and post-migration validation.
- Conduct data reconciliation between source and target systems to ensure completeness, accuracy, and compliance of migrated data.
- Design, develop, customize, and maintain Oracle BI Publisher (BIP) reports, line listings, and regulatory outputs based on business requirements.
- Create and optimize complex data models, templates, and report layouts within Oracle BI Publisher.
- Support generation and validation of operational, regulatory, and management reports using BIP and database queries.
- Develop and optimize SQL queries, stored procedures, and scripts to support reporting, migration, and data analysis requirements.
- Collaborate with technical teams to support integrations, data interfaces, and reporting solutions across pharmacovigilance systems.
- Participate in system upgrades, enhancements, and migration projects, ensuring reporting and data validation requirements are met.
- Prepare and maintain migration documentation, validation evidence, test scripts, SOPs, and technical specifications.
- Ensure migrated data and reporting processes comply with pharmacovigilance regulations and organizational data governance standards.
- Provide end-user support and training related to migration deliverables, reporting solutions, and BI Publisher reports.
- Monitor reporting performance and recommend process improvements to enhance efficiency, accuracy, and compliance.
- Stay current with Oracle BI Publisher enhancements, data migration best practices, and emerging pharmacovigilance technologies.
- PREFERRED QUALIFICATIONS:
- Bachelor’s degree/Masters Degree in IT Stream
- 3+ years of relevant experience in drug safety IT Systems
Additional Information
All your information will be kept confidential according to EEO guidelines.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.
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Company Description
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!
Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.