Safety Reporting Business Application Specialist - Hyderabad

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Pharmacovigilance Job Category: Scientific/Technology All Job Posting Locations: Hyderabad, Andhra Pradesh, India Job Description: Position Title: Safety Reporting Business Application Specialist - Hyderabad Position Summary The main purpose of the Safety Reporting Business Application Specialist position is: To provide operational pharmacovigilance expertise and business systems support for global safety reporting activities and systems. The role will combine a strong understanding of day-to-day safety reporting requirements with the systems knowledge needed to support Global Safety Reporting leadership and activities across the safety reporting software development lifecycle. The role will act as a bridge between safety reporting business users, the Business Application Owner, development teams, and external vendors. It will translate regulatory and operational needs into clear business and functional requirements for system configuration. Key responsibilities may include: · Providing hands-on technical and operational support for safety reporting systems, interfaces, data flows, and automated processes. · Supporting the Safety Reporting Manager/Associate Director with system development, maintenance, Level 3 incident investigation, enhancements, validation, and SDLC documentation · Contributing to the design, configuration, testing, implementation, and post-deployment support of Safety Reporting system changes. · Understanding complex database integrations, interface logic, coding concepts, data mappings, and system dependencies. · Translating safety reporting business needs and regulatory requirements into business and functional solutions. · Supporting compliant and timely distribution of SUSARs, SUSAR Line Listings, and Development Safety Update Reports. Major Duties & Responsibilities Major responsibilities are listed in order of approximate percentage of time. The percentages may vary according to project and operational priorities. Tasks / Duties / Responsibilities Safety Reporting Operations & Business Analysis - 55% · Provide subject matter expertise for global safety reporting activities, including SUSARs, SUSAR Line Listings, and Development Safety Update Reports, and ensure system solutions support timely and accurate distribution to investigators, Independent Ethics Committees, and Institutional Review Boards in line with applicable requirements. · 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 whether proposed technical solutions meet 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, communicating complex technical topics in clear business language and explaining business requirements to technical teams. · Identify opportunities for automation, control improvements, simplification, and improved user experience without compromising compliance. Business Application Support & System Lifecycle Management - 35% · Support the Safety Reporting Manager/Associate Director in the operation, maintenance, monitoring, and continuous improvement of safety reporting applications throughout their lifecycle. · Analyze system architecture, interfaces, data flows, business rules, and dependencies to assess operational impact and support business decisions. Work with technical teams to investigate incidents, identify root causes, assess business impact, and define sustainable corrective solutions. · Review proposed system designs, interfaces, and configurations from a business and compliance perspective. · Support data queries, reconciliation, troubleshooting, and technical analysis using appropriate database and reporting tools. · Contribute to the design, configuration, testing, validation, release readiness, deployment, and post-deployment support of safety reporting system changes. Maintain clear business and functional documentation to support system reliability, knowledge transfer within Global Safety Reporting, audit readiness, and business continuity. 10% Quality, Documentation & Training - 10% · Support controlled documentation, including procedures, work instructions, system lifecycle documentation, validation records, training materials, and support guides. · Ensure work is performed in accordance with applicable quality standards, departmental procedures, and system lifecycle requirements. · Provide audit and inspection support by supplying accurate system, process, testing, and issue-management evidence. · <span style="