Project Role Business Analyst Project Role Description Analyze an organization and design its processes and systems assessing the business model and its integration with technology Assess current state identify customer requirements and define the future state and or business solution Research gather and synthesize information Must have skills Business Requirements Analysis Pharmacovigilance Drug Safety Surveillance Life sciences Business Analyst Good to have skills NA Minimum 5 year s of experience is required Educational Qualification 15 years full time education Summary As a Business Analyst you will analyze an organization and design its processes and systems assessing the business model and its integration with technology Your typical day will involve collaborating with various stakeholders to understand their needs conducting thorough research to gather relevant information and synthesizing this data to propose effective business solutions You will also assess the current state of operations and identify customer requirements to define the desired future state ensuring alignment with organizational goals and technology capabilities Your role will be pivotal in bridging the gap between business needs and technological solutions facilitating informed decision-making and strategic planning Roles Responsibilities 1 Business Analysis - Act as a SME in Drug Safety and Pharmacovigilance for Veeva Vault ensuring compliance with regulatory standards - Lead workshops to gather system requirements and create actionable plans for Veeva Vault setup - Design and customize Veeva Vault to meet business and regulatory needs FDA EMA ICH - Document requirements URS FS User Stories and develop test scripts to validate system performance 2 Stakeholder Management - Serve as primary contact between customers teams and stakeholders for smooth project delivery - Work with Product Owners to prioritize tasks manage backlogs and align with customer expectations - Build and maintain solid relationships with stakeholders to ensure their needs are met - Involve contribute to RFPs to support business development efforts 3 Life Sciences Domain Knowledge - Ensure compliance with industry standards FDA EMA ICH in Drug Safety and Pharmacovigilance - Provide ongoing support to optimize Veeva Vault post-implementation 4 Agile Delivery - Collaborate with Product Owners to manage backlogs and prioritize user stories - Lead agile delivery to ensure timely high-quality solutions 5 Engagement - Lead and mentor cross-functional teams throughout the project lifecycle fostering a collaborative environment to ensure the successful delivery of Veeva Vault Safety solutions Provide guidance support and direction to team members while maintaining alignment with business goals timelines and quality standards ensuring client satisfaction and continuous project success - Lead change management for clients transitioning to Veeva Vault ensuring smooth adoption - Define deployment plans and post-go-live strategies for continued success Professional Technical Skills 1 Industry-Specific Knowledge Tools - Leverage Veeva Vault for pharmacovigilance solutions and ensure compliance with regulations - Stay current with industry tools and technologies for effective system implementation 2 Tools Technologies - Veeva Vault Safety - JIRA Project Management Backlog Management - Confluence Documentation Collaboration - HP-ALM Q-Test Test Management - MS Office Suite Excel Word PowerPoint Visio - Veeva QMS Quality Management System - Pharmacovigilance Software e g Argus ArisGlobal - SQL Oracle Database Management Querying - Medidata TMF eCRF 3 Skills - Effective Communication Verbal Written - Client Relationship Management - Cross-functional Collaboration - Understanding of GxP ICH FDA EMA Guidelines - Knowledge of Medical Terminology Safety Reporting e g MedDRA WHO Drug - Compliance with Global Regulations FDA EMA ICH E2E - Basic Coding Knowledge SQL XML - Leadership Team Management - Mentoring Coaching Junior Team Members - Critical Thinking Problem-Solving Additional Information - The candidate should have minimum 5 years of experience in Business Requirements Analysis - This position is based at our Bengaluru office - A 15 years full time education is required 15 years full time education

📌 Business Analyst (Karnataka)
🏢 Accenture
📍 Karnataka