Safety Reporting Business Application Specialist - Hyderabad

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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.

·  Deliver business process and system-use training

·  Deliver technical and process training to users and provide ongoing guidance following system changes or implementation.

·  Maintain current knowledge of pharmacovigilance regulations, safety reporting practices, safety reporting systems, data flows, integration concepts, and relevant business tools, database technologies, system integration methods, and relevant technical tools.

Perform other duties that are consistent with the role and may be assigned according to business, regulatory, operational, or project needs.

Key Working Relationships

Internal

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

eSUSAR distribution system vendor, outsourcing vendor teams, software developers, technical support teams, implementation partners, and other service providers.

Decision Making Authority

Decision Making Authority

·  Trains employees and system users within the scope of assigned responsibilities.

·  Recommends technical and process solutions based on documented business, regulatory, quality, and system requirements.

·  Escalates system, data, compliance, and delivery risks through appropriate governance channels.

·  Does not make hiring, pay, promotion, termination, grievance, or budget decisions.

Required Qualifications

Required Minimum Education:
Bachelor’s degree in life sciences, pharmacy, computer science, information systems, engineering, data science, or a related discipline, or equivalent relevant experience.

Required Years of Related Experience:
Previous pharmaceutical industry, clinical, pharmacovigilance, or safety systems experience, typically demonstrated by a minimum of 8+ years of relevant experience. Experience must include practical knowledge of safety reporting operations and involvement in technical system support, system implementation, database integration, or business analysis.

Required Knowledge, Skills and Abilities:

Pharmacovigilance & Regulatory Expertise

·  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.

Business Applications, Systems & Data.

·  Strong technical aptitude and the 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 the 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.

Business Analysis & Communication

·  Demonstrated 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 with the 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. le Requirements

Preferred Qualifications

Preferred Minimum Education:
Bachelor’s degree or higher in a relevant life science or technical discipline.

Preferred Area of Study:
Life sciences, pharmacy, pharmacovigilance, computer science, information systems, engineering, data science, or a related field.

Preferred Related Industry Experience:
Experience with pharmacovigilance technology platforms, eSUSAR distribution systems, regulated system implementation, data migration, or digital transformation projects.

Preferred Knowledge, Skills and Abilities:
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.

Key Working Relationships

Travel on the Job:
Yes

Percentage Traveled:
<5%

Type of Travel Required:
Domestic and international, as needed

People Management Experience:
No

Required Years of People Management Experience:
N/A

Supervisory Responsibility:
Direct reports: 0; Indirect reports: 0

Required Skills:

Preferred Skills:
Clinical Operations, Coaching, Critical Thinking, Cross-Functional Collaboration, Health Intelligence, Performance Measurement, Pharmacovigilance, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy