Job
Description
About The Role
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 ManagementServe 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 strong relationships with stakeholders to ensure their needs are met.Involve & contribute to RFPs to support business development efforts.3. Life Sciences Domain KnowledgeEnsure compliance with industry standards (FDA, EMA, ICH) in Drug Safety and Pharmacovigilance.Provide ongoing support to optimize Veeva Vault post-implementation.4. Agile DeliveryCollaborate with Product Owners to manage backlogs and prioritize user stories.Lead agile delivery to ensure timely, high-quality solutions.5. EngagementLead 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 & ToolsLeverage Veeva Vault for pharmacovigilance solutions and ensure compliance with regulations.Stay current with industry tools and technologies for effective system implementation.2.Tools & TechnologiesVeeva Vault SafetyJIRA (Project Management, Backlog Management)Confluence (Documentation, Collaboration)HP-ALM, Q-Test (Test Management)MS Office Suite:Excel, Word, PowerPoint, VisioVeeva QMS (Quality Management System)Pharmacovigilance Software (e.g., Argus, ArisGlobal)SQL / Oracle (Database Management, Querying)Medidata, TMF, eCRF3. SkillsEffective Communication (Verbal & Written)Client Relationship ManagementCross-functional CollaborationUnderstanding of GxP, ICH, FDA, EMA GuidelinesKnowledge 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 ManagementMentoring & Coaching Junior Team MembersCritical 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.
Qualification 15 years full time education
