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 expertis...