Safety Reporting Business Application Specialist - Hyderabad

Overview

The Safety Reporting Business Application Specialist provides operational pharmacovigilance expertise and business systems support for global safety reporting activities and systems. The role bridges safety reporting business users, the Business Application Owner, development teams, and external vendors across the safety reporting software development lifecycle.

What you'll do

• Provide hands-on technical and operational support for safety reporting systems, interfaces, data flows, and automated processes.
• Support the Safety Reporting Manager/Associate Director with system development, maintenance, Level 3 incident investigation, enhancements, validation, and SDLC documentation.
• Contribute to the design, configuration, testing, implementation, validation, release readiness, deployment, and post-deployment support of safety reporting system changes.
• Provide subject matter expertise for global safety reporting activities, including SUSARs, SUSAR Line Listings, and Development Safety Update Reports, and support timely and accurate distribution to investigators, Independent Ethics Committees, and Institutional Review Boards.
• Interpret business processes, regulatory requirements, reporting rules, and user needs and translate them into functional and non-functional requirements, process flows, user stories, use cases, acceptance criteria, data requirements, and impact assessments.
• Assess proposed technical solutions against safety reporting business, regulatory, data integrity, security, and operational continuity needs.
• Design and execute user acceptance testing, document results, manage defects, and support traceability from requirements through implementation.
• Act as a key link between Global Safety Reporting users, Information Technology, system developers, vendors, and other stakeholders.
• Identify opportunities for automation, control improvements, simplification, and improved user experience without compromising compliance.
• Analyze system architecture, interfaces, data flows, business rules, and dependencies to assess operational impact and support business decisions.
• Investigate incidents with technical teams, identify root causes, assess business impact, and define sustainable corrective solutions.
• Support data queries, reconciliation, troubleshooting, and technical analysis using appropriate database and reporting tools.
• Maintain business and functional documentation for system reliability, knowledge transfer, audit readiness, and business continuity.
• Support controlled documentation, including procedures, work instructions, system lifecycle documentation, validation records, training materials, and support guides.
• Provide audit and inspection support by supplying system, process, testing, and issue-management evidence.
• Deliver business process, system-use, technical, and process training and provide ongoing user guidance.
• Maintain current knowledge of pharmacovigilance regulations, safety reporting practices, safety reporting systems, data flows, integration concepts, business tools, database technologies, system integration methods, and relevant technical tools.
• Train employees and system users within the scope of assigned responsibilities.
• Recommend technical and process solutions based on documented business, regulatory, quality, and system requirements.
• Escalate system, data, compliance, and delivery risks through appropriate governance channels.
• Perform other duties consistent with the role as assigned according to business, regulatory, operational, or project needs.

What you'll need

• Bachelor’s degree in life sciences, pharmacy, computer science, information systems, engineering, data science, or a related discipline, or equivalent relevant experience.
• Minimum of 8+ years of relevant experience, including previous pharmaceutical industry, clinical, pharmacovigilance, or safety systems experience.
• Practical knowledge of safety reporting operations and involvement in technical system support, system implementation, database integration, or business analysis.
• Strong working knowledge of pharmacovigilance operations and global safety reporting, including individual case safety reports, SUSARs, SUSAR Line Listings, and Development Safety Update Reports.
• Ability to understand reporting requirements, operational controls, data quality expectations, and the compliance impact of system changes or failures.
• Experience working in a regulated environment and supporting inspection-ready processes and documentation.
• Strong technical aptitude and ability to understand complex databases, application architecture, interfaces, integrations, data models, data mappings, business rules, and automated workflows sufficiently to assess business and operational impact.
• Ability to review and discuss system designs, interface specifications, and configuration proposals with technical teams.
• Practical experience with database querying, preferably SQL, and ability to analyze data, investigate discrepancies, and support reconciliation activities.
• Understanding of application programming interfaces, structured data exchange, system-to-system integrations, and common integration failure points.
• Experience supporting system incidents, root-cause analysis, change control, releases, upgrades, testing, validation, and defect management.
• Ability to convert business and regulatory needs into clear functional and non-functional requirements, user stories, process flows, acceptance criteria, and test scenarios.
• Ability to explain technical concepts clearly to non-technical stakeholders and communicate business context precisely to technical teams.
• Strong analytical, problem-solving, documentation, and stakeholder-management skills.
• Ability to identify opportunities for automation, simplification, and improved user experience without compromising compliance.
• Ability to manage multiple priorities, work with global cross-functional teams, and operate effectively across ongoing system lifecycle and operational support activities.

Nice to have

• Bachelor’s degree or higher in a relevant life science or technical discipline.
• Life sciences, pharmacy, pharmacovigilance, computer science, information systems, engineering, data science, or a related field of study.
• Experience with pharmacovigilance technology platforms, eSUSAR distribution systems, regulated system implementation, data migration, or digital transformation projects.
• Hands-on experience with SQL or another query language; application programming interfaces; structured data formats; integration or middleware platforms; cloud-based applications; reporting or analytics tools; Agile delivery; and regulated system lifecycle or validation practices.

Details

• Location: Hyderabad, Andhra Pradesh, India.
• Travel is required, including domestic and international travel as needed.
• People management experience is not required; the role has 0 direct reports and 0 indirect reports.
• Internal working relationships include Global Safety Reporting, Global Case Management, Global Development, Information Technology, Quality, Data Privacy, Information Security, Procurement, Legal, Regulatory, and other system or process stakeholders.
• External working relationships include the eSUSAR distribution system vendor, outsourcing vendor teams, software developers, technical support teams, implementation partners, and other service providers.
• The role does not make hiring, pay, promotion, termination, grievance, or budget decisions.