Roles & Responsibilities
• Analyze organizational processes, business models, and system integrations with technology
• Act as Subject Matter Expert (SME) in Drug Safety and Pharmacovigilance for Veeva Vault Safety
• Lead requirement-gathering workshops and define system requirements for Veeva Vault implementation
• Assess current-state processes and define future-state business solutions aligned with regulatory needs
• Design and configure Veeva Vault to meet FDA, EMA, and ICH regulatory requirements
• Document business and system requirements including URS, FS, and user stories
• Develop test scripts and support system validation and UAT activities
• Serve as the primary liaison between customers, stakeholders, and delivery teams
• Collaborate with Product Owners to manage backlogs, prioritize user stories, and support agile delivery
• Participate in RFPs and support business development initiatives
• Ensure compliance with global Drug Safety and Pharmacovigilance regulations
• Provide post-implementation support and optimization for Veeva Vault Safety solutions
• Lead change management activities to support client transition to Veeva Vault
• Define deployment strategies and post–go-live support plans
• Mentor and guide cross-functional teams to ensure successful project delivery
Qualification
• 15 years of full-time education (Bachelor’s degree or equivalent)
Experience
• Minimum 5 years of experience in Business Requirements Analysis
• Hands-on experience as a Life Sciences / Pharmacovigilance Business Analyst
• Experience working on Drug Safety and Pharmacovigilance systems preferred
Skills
• Strong expertise in Business Requirements Analysis
• In-depth knowledge of Pharmacovigilance & Drug Safety Surveillance
• Hands-on experience with Veeva Vault Safety
• Familiarity with PV systems such as Argus, ArisGlobal
• Knowledge of GxP, ICH, FDA, EMA, and global safety regulations (ICH E2E)
• Understanding of medical terminology and safety dictionaries (MedDRA, WHO Drug)
• Experience with Agile delivery models and backlog management
• Proficiency in tools such as JIRA, Confluence, HP-ALM, Q-Test
• Working knowledge of SQL, Oracle, XML, Medidata, TMF, eCRF
• Strong documentation, communication, and stakeholder management skills
• Leadership, mentoring, and cross-functional collaboration abilities
• Strong analytical, critical thinking, and problem-solving skills
About the Organisation
The organization operates at the intersection of life sciences and digital transformation, delivering technology-enabled solutions for Pharmacovigilance, Drug Safety, and regulatory compliance. With a strong focus on Veeva Vault implementations and global regulatory standards, it supports pharmaceutical and life sciences clients in optimizing safety operations, ensuring compliance, and driving efficient, high-quality system delivery across global programs.
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