Specialist GxP Product Analysis Pharmacovigilance IT

About the role

Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's' IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview The Pharmacovigilance (PV) IT Product Analyst is responsible for partnering with PV business stakeholders and IT teams to understand, document, and translate business and regulatory needs into clear system requirements and validated solutions. This role supports the lifecycle of PV systems and analytics tools, ensuring they operate in a GxP-compliant, efficient, and audit-ready manner. The analyst contributes to system enhancements, validation documentation, testing support, and ongoing product optimization across PV applications. What will you do in this role Understand business needs related to multiple PV systems and platforms Translate business needs, user requests, and regulatory requirements into clear, testable requirements and acceptance criteria Author, review, and maintain SDLC documentation required for GxP-compliant software development and validation, including: Business requirements Functional requirements User stories / use cases Test strategies and test scripts Requirements traceability documentation Validation and release documentation Support system configuration, enhancement requests, incident resolution, and change control activities Collaborate with PV stakeholders, IT, QA, vendors, and validation teams to ensure solutions meet business and compliance expectations Support test planning, test execution, UAT coordination, and defect management Ensure documentation is complete, accurate, and aligned with internal standards and regulatory expectations Assist in identifying opportunities to improve PV processes, reporting, workflow efficiency, and data quality Support validation activities for new implementations, upgrades, interfaces, and periodic system changes Maintain awareness of PV regulations, data integrity requirements, and computer system validation practices Work with reporting and analytics teams to support PV dashboards, metrics, and operational reporting needs Participate in backlog refinement, prioritization discussions, and release planning for PV products What should you have Primary Skills 3-5 years of experience with PV applications and strong understanding of pharmacovigilance business processes Ability to translate business and regulatory requirements into clear, testable requirements Experience authoring and maintaining SDLC and validation documentation for GxP systems Requirements management and stakeholder communication Support for testing, UAT, defect tracking, and change control Attention to detail and strong documentation skills Preferred Knowledge of Agile or hybrid project delivery Exposure to reporting and analytics tools Familiarity with data interfaces and system integrations Previous experience in a global regulated environment This role represents an exceptional opportunity to help ensuring that pharmacovigilance systems are reliable, compliant, and aligned with business needs so that safety operations can run efficiently and in accordance with regulatory expectations. We are known as well-known org Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatmen

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Job Description Pharmacovigilance (PV) IT Product Analyst

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