Please see below the company profile links and the job description for your reference. If you are interested share your CV at: tripti.kumari@ultragenicglobal.com Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Experience: 3+ Years Job Description: Hands on experience on Woking with GITHUB for business. Able to troubleshoot issues related to GITLAB/GITHUB setup. Configuring GITLAB runners, configuring GITLAB groups. Creating, troubleshooting issues in CI/CD pipelines. Able to write and troubleshoot complex python scripts and good understanding on Boto3 library. Deep understanding of Cloud Formation and Terraform scripts. Good knowledge on Linux Operating System components. Hands on experience on Serverless architecture designing / implementation. Hands on experience on microservice architecture and good working knowledge of Kubernetes, Docker etc., Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com
I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com
Ultragenic brings together Life sciences domain expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across the Pharmacovigilance function. Our solutions are agile, flexible and scalable, developed using advance technologies such as AI, Machine learning and Robotic process automation that enable us to serve large and small organizations, both in developed and emerging markets. With rich experience in engineering and deploying best-in-class life sciences solutions, our team is well placed to help achieve your goals. Skills Experience of design, development and deployment of multi-dimensional reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Experience in Oracle PL/SQL and writing efficient SQL queries. Experience of creating excel based and RTF template based OBIEE Reports is a plus. Good experience in database concepts, and any ETL tool is added advantage. Good understanding of DW concepts and Analytical skills. Good experience in Performance tuning to ensure reports function within acceptable parameters. Good to have pharmacovigilance domain exposure. Responsibilities Work with business users to design and develop Custom Reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Prepare all designs and code for various Custom Reporting objects and ensure compliance with all best business practices in the industry. Understand business requirements, relational databases, and data models. Authoring of installation specifications and execution of unit testing. Be responsible for authoring project documentation/deliverables. Facilitate/contribute to client demo sessions/workshops.
Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should have strong understanding of pharmacovigilance, regulations and guidelines for difference geographic location. Should have experience in reviewing the CSV deliverables such as IQ, OQ and PQ scripts. Experience of QA in FDA / EMEA regulated environment is preferred.
As a CSV (Computer System Validation) Consultant/ Lead your responsibilities includes developing validation plans, protocols, and test scripts; executing tests; performing risk assessments; documenting all processes; and ensuring that systems adhere to regulatory requirements throughout the lifecycle. Required Skills and Qualifications Technical Skills: Proficiency with validation software (e.g., MS Project, ALM, Veeva Vault) and an understanding of manufacturing and supply chain applications. Regulatory Knowledge: Strong understanding of GxP, FDA regulations, and other relevant industry standards. Analytical and Problem-Solving Skills: Ability to assess systems for quality and compliance, analyze deviations, and provide logical solutions. Communication Skills: Excellent ability to communicate effectively with different teams and clients. Attention to Detail: Meticulous focus on accuracy, thoroughness, and ensuring all tasks and details are handled correctly. Education: Bachelor's degree in a technical field like Computer Science or Engineering, along with relevant experience. Key Role and Responsibilities: Should have experience in CSV (Computer System Validation) in Life Sciences domain. Should have good knowledge of GxP regulations and GAMP 5 Guidelines. Should have a good knowledge of 21 CFR part 11 and EU Annex 11 regulations. Should have experience in defining the validation strategy, approach, and alignment with customer on QMS. Should have good knowledge of Good Documentation Practices. Should have experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Should have experience of Validating Safety Systems. Should have strong understanding of pharmacovigilance, regulations and guidelines for difference geographic location. Should have experience in reviewing the CSV deliverables such as IQ, OQ and PQ scripts. Experience of QA in FDA / EMEA regulated environment is preferred. Interested candidate can share their CV directly on my email ID: s
1. Purpose of the Position The primary purpose of this position is to serve as a crucial bilingual (English & Mandarin) technical resource, providing as an expert on consulting, hosting, and managed services for our clients in the global pharmacovigilance (PV) industry mainly for China local clients. This role is responsible for ensuring the optimal implementation, operation, and support of PV technology solutions, acting as the key contact person between our clients' business needs and our technical delivery team. 2. Responsibilities Consulting & Solution Implementation: Work directly with clients to gather and analyze business requirements for PV systems and related automatic solution needs. Translate business requirements into functional and technical specifications. Configure and customize PV applications to meet client-specific workflows and regulatory needs. Provide expert guidance on best practices in PV process automation and system optimization. Act as a contact person between clients, the global team, and our headquarters in India for technical issue. Facilitate clear and timely communication, ensuring requirements and project updates are accurately conveyed across all stakeholders. Coordinate with technical and functional teams at the India headquarters for development, escalation, and implementation support. Hosting & Infrastructure Management: Manage the deployment and maintenance of PV applications in various hosting environments (cloud, on-premise, hybrid). Perform routine system administration, monitoring, and performance tuning to ensure high availability and reliability. Coordinate with infrastructure teams to ensure security and compliance with global data protection regulations (e.g., GDPR, HIPAA). Managed Services & Support: Act as a primary point of contact for clients, providing Tier 2/3 technical support and incident management. Proactively manage system health, apply patches, and execute planned upgrades. Deliver ongoing application management, including user access control, report customization, and ad-hoc client requests. Client Relationship & Communication: Facilitate clear and effective communication between the Chinese-speaking clients and the global technical team. Prepare and deliver regular service reports, project updates, and technical documentation in both English and Chinese. 3. Expected Outcomes High Client Satisfaction: Achieve and maintain high client satisfaction scores through responsive, professional, and effective service delivery. Successful Project Delivery: Contribute to the successful, on-time, and on-budget implementation of PV projects for new and existing clients. Effective Issue Resolution: Rapidly diagnose and resolve technical issues, minimizing downtime and impact on client operations. Knowledge Transfer: Effectively document solutions and train client users to ensure smooth adoption and operation of the systems. 4. Required Skills & Qualifications Technical Skills: Bachelor's degree in Computer Science, Information Technology, or a related field. 1+ years of experience in IT consulting, application support, or system administration is preferred. Fresh graduates with bachelor or master degrees are also acceptable. Hands-on experience with databases and writing SQL queries (Oracle, MS SQL Server). Practical knowledge of operating systems (Windows Server, Linux) and networking concepts. Experience with cloud platforms (e.g., AWS, Azure) is a strong plus. Functional Skills (Pharmacovigilance Domain)-to be trained: Proven experience working with major Pharmacovigilance software (e.g., Oracle Argus Safety, ArisGlobal, Veeva Vault Safety) is a significant advantage . Understanding of end-to-end pharmacovigilance processes and global PV regulations (e.g., FDA 21 CFR Part 11, EudraVigilance Requirements). Ability to understand and translate PV business requirements (case processing, reporting, signal detection) into technical solutions. Language & Soft Skills: Full professional proficiency in both Mandarin Chinese and English is essential (both verbal and written). Excellent client-facing communication and interpersonal skills. Strong analytical and problem-solving abilities. A process-oriented and meticulous working style. Ability to work independently and as part of a globally distributed team. 5. Reporting Structure The Bilingual IT Consultant will report directly to the Country Director . This role will work closely with the Project Management Office (PMO), Technical Operations team, and other Consultants. This position has no direct reports. Interested candidates please share your CV directly at: tripti.kumari@ultragenicglobal.com
I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com
I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com