Safety Systems Analyst I at Vantive in Bengaluru, Karnataka, India

Safety Systems Analyst I Location: Bangalore, Karnataka Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. This position is a member of Global Patient Safety (GPS) – Safety Operations, Safety Systems and Data Management. The Safety Systems Analyst I serves as the Subject matter expert and is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking. The Safety Systems Analyst I acts as a technical subject matter expert responsible for managing routine to medium‑complexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules. The position works with internal GPS functional areas as well as vendor resources to review and implement routine to medium-complexity system changes, including updates to reporting rules. This role is based in Whitefield, Bangalore, with periodic requirement to support global users across multiple time zones. Essential Duties and Responsibilities Supporting the maintenance of current pharmacovigilance safety systems (ARGUS and PVQ). Collaborate with IT teams and vendor resources to plan and implement system-related changes (Routine Changes and Change Requests). Implements approved routine and medium‑complexity system changes under established change control and validation frameworks; escalates complex or high‑risk changes to senior system analysts or management. Initiation, review, and notification of routine changes to pharmacovigilance safety systems. Review and analysis of user requirements prior to approval and implementation. Participate in system validation activities (IQ/OQ/PQ or equivalent) in accordance with internal SOPs and regulations. Perform periodic review of administrator data including, but not limited to, user access, company product dictionary, and Safety Data Exchange agreements. Ensure that changes made to databases are controlled through the change control process. Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional areas prior to processing for implementation. Responsible for creating, verifying, and tracking routine system change requests, including to reporting rules, product lists, codelists, reports and dashboards. Drive consistent interpretation of system-related conventions, specifications, and definitions when making configuration changes. Maintain and manage SharePoint sites used for tracking system requests (Routine Changes and Change Requests). Take initiative to recognize, prioritize, and escalate potential safety or compliance issues. Provide knowledge sharing and procedural guidance to new or junior team members, as assigned. Escalate system, compliance, capacity or workload concerns to management in a timely manner in accordance with escalation procedures. Ensure data integrity and audit trail completeness of pharmacovigilance safety systems. Support internal audits, health authority inspections, and inspection readiness activities related to pharmacovigilance safety systems. Qualifications Strong technical understanding of pharmacovigilance database systems. Excellent analytical and problem-solving skills. Strong knowledge of Pharmacovigilance system (e.g. ARGUS) with good understanding of the database structure and application architecture Strong technical system skills (e.g. Microsoft Office Tools, Power BI, SharePoint, SQL and Databases) Strong knowledge of pharmacovigilance terminology and understanding of data entry conventions Excellent oral and written communication skills with attention to detail Excellent interpersonal skills that encourage teamwork Ability to work independently under strict deadlines and changing priorities. Ability to multitask and prioritize changing workload for self and others on daily basis. Broad knowledge/understanding of relevant ICH guidelines, as well as global regulations (incl. FDA, EMA, PMDA,…). Problem Solving- Identify priorities and key issues in complex situations and formulate and execute issue resolution with minimal assistance. Education and/or Experience. Bachelor’s degree in Computer Science, Life Sciences, Pharmacy, or equivalent. Minimum 2 – 4 years of experience in Pharmacovigilance, PV systems support, or related areas. Good understanding ARGUS Safety System. Good understanding of system change management, validation, and compliance processes. Exposure to Microsoft Power Platform is preferred Strong documentation and communication skills. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. 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