2 Pharmacovigilance Domain Jobs

As a Senior Data Specialist - Reporting in Pharmacovigilance (PV) at our client's leading provider of Pharmacovigilance (PV) Technology Solutions in Noida, India, your primary responsibility will be to design, develop, and deploy multi-dimensional reports using BI Tools, preferably Cognos or OBIEE Business Intelligence solution. With a minimum of 6 years of experience in the PV domain, you will leverage your expertise in Oracle PL/SQL to write efficient SQL queries and create excel-based and RTF template-based OBIEE Reports. Your role will entail a good understanding of database concepts and the ability to work with any ETL tool, while also demonstrating proficiency in DW concepts and analytical skills. Performance tuning to ensure reports function within acceptable parameters will be a key aspect of your responsibilities. Collaborating with business users, you will design and develop Custom Reports using BI Tools, ensuring compliance with industry best practices. Your tasks will include preparing designs and code for various Custom Reporting objects, understanding business requirements, relational databases, and data models, as well as authoring installation specifications and executing unit testing. Additionally, you will be accountable for authoring project documentation/deliverables and contributing to client demo sessions/workshops. Our client values inclusivity and diversity in the workplace and offers competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development. If you have a B. Tech/B.E./MCA education background and a strong track record in the PV domain, we encourage you to submit your resume and cover letter highlighting your relevant experience and achievements in AI/ML Technologies. We are excited to review your application and potentially welcome you to our client's dynamic team.,

Date: 29th July 2024 Job Status: Full Time Job Location: Noida, India Summary We are seeking a Director of Automation specializing in Unified Functional Testing (UFT) at RxLogix, an innovative company developing cutting-edge software for the pharmaceutical industry. The ideal candidate will have a deep understanding of UFT, experience in the pharmacovigilance domain, and the ability to lead high-performing teams to build enterprise-class software products. Role Purpose Lead and own automation product testing team to build high quality enterprise class software products for Pharmacovigilance industry. Define and drive the automation product testing strategies and ways to achieve companies goal of 100% automated testing, plans and activities for various product releases as per RxLogix product development agile SDLC. Description Strategic Leadership in Automation: Develop and drive the automation strategy using UFT, aligning with RxLogixs objectives and agile SDLC. Lead the automation initiatives across multiple projects with complete ownership. Team Management and Development: Lead, mentor, and manage a team of 15+ automation test engineers and validation professionals, fostering a strong validation and testing culture. Define growth plans, set objectives, review performances, and nurture a collaborative environment. Quality and Compliance Oversight: Ensure high-quality product testing and validation in compliance with 21 CFR Part 11, EU Annex 11, GAMP5, GxP, and CSV guidelines. Guide the testing team members for automation testing activities and artefacts including (but not limited to) system testing, functional testing and automation testing (including OQ, PQ, IQ, etc.) Collaboration and Integration: Liaise with department heads from Development, Product Management, and Quality to deliver quality and timely product releases. Collaborate with technical managers, automation architects, and product owners to build automation framework which helps in achieving the organization goals. Process Improvement and Metrics: Drive continuous process and tool improvement for efficient, quality, and timely delivery. Collaborate with other department heads and company leadership on continuous process improvement. Build and run a metrics-driven organization, focusing on innovation, operational excellence, and best practices in an Agile environment. Timely and Quality Releases: Ensure timely and quality release of various product releases as per RxLogix Agile SDLC with appropriate oversight, monitoring and intervention. Resource Management: Predict, maintain, and execute resource hiring requirements. Manage the setup, costing, and maintenance of product environments needed by the team. Mentor his/her team by providing career development goals, semi-annual reviews, and advocating for their career advancement. Customer Satisfaction: Ensure customer satisfaction for product quality. Audit and Compliance: Represent his/her department to clients, company leadership, inspections, and audit (external and internal) and drives RCA, action plans and CAPAs to closure. Hiring: Support company growth by building and maintaining a strong professional network as well as contributing to the recruitment of new employees. Must Have Qualifications: Bachelors or Masters degree in Computer Science, Management, or related field from a top college. Overall, 15-20 years of experience, with a minimum of 5-10 years in managing high-performing testing and validation teams. Expertise in Unified Functional Testing (UFT) and experience in the pharmacovigilance industry. Profound knowledge of Unified Functional Testing, including scripting, debugging, and test execution. Proficiency in VBScript, which is used for scripting in UFT. Knowledge of additional programming languages like Java or C# is a plus. Ability to design and develop robust automation frameworks that are reusable, scalable, maintainable, and efficient. Skills in developing comprehensive test strategies and plans that align with project objectives and timelines. Ability to analyze requirements, test results, and identify areas of improvement in the automation process. Proven leadership skills in software product quality and delivery management. Efficient in handling multiple products and teams with competing priorities. Pharmacovigilance domain knowledge and experience of working with top pharma companies and pharmacovigilance products like Argus, ArisG is highly preferred. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP5, GxP and CSV guidelines that are applicable to life sciences industry is highly preferred. Solid understanding and experience of Agile tool such as JIRA, Confluence and all Microsoft Office Tools. Strong focus on quality delivery and SDLC compliance. Self-motivated, leadership capabilities, strong organizational skills, action and results oriented. Demonstrated ability to meet commitments, build consensus, negotiate resolutions, and garner respect from other teams. Excellent communication and client/audit handling skills. Willingness to travel for 1-2 weeks short business trips occasionally within the country and to other countries if needed to meet clients and internal stakeholders.,