Specialist GxP Product Analysis Pharmacovigilance IT

Job DescriptionPharmacovigilance (PV) IT Product AnalystThe OpportunityBased 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 OverviewThe 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 roleUnderstand business needs related to multiple PV systems and platformsTranslate business needs, user requests, and regulatory requirements into clear, testable requirements and acceptance criteriaAuthor, review, and maintain SDLC documentation required for GxP-compliant software development and validation, including:Business requirementsFunctional requirementsUser stories / use casesTest strategies and test scriptsRequirements traceability documentationValidation and release documentationSupport system configuration, enhancement requests, incident resolution, and change control activitiesCollaborate with PV stakeholders, IT, QA, vendors, and validation teams to ensure solutions meet business and compliance expectationsSupport test planning, test execution, UAT coordination, and defect managementEnsure documentation is complete, accurate, and aligned with internal standards and regulatory expectationsAssist in identifying opportunities to improve PV processes, reporting, workflow efficiency, and data qualitySupport validation activities for new implementations, upgrades, interfaces, and periodic system changesMaintain awareness of PV regulations, data integrity requirements, and computer system validation practicesWork with reporting and analytics teams to support PV dashboards, metrics, and operational reporting needsParticipate in backlog refinement, prioritization discussions, and release planning for PV productsWhat should you havePrimary Skills3-5 years of experience with PV applications and strong understanding of pharmacovigilance business processesAbility to translate business and regulatory requirements into clear, testable requirementsExperience authoring and maintaining SDLC and validation documentation for GxP systemsRequirements management and stakeholder communicationSupport for testing, UAT, defect tracking, and change controlAttention to detail and strong documentation skillsPreferredKnowledge of Agile or hybrid project deliveryExposure to reporting and analytics toolsFamiliarity with data interfaces and system integrationsPrevious experience in a global regulated environmentThis 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.Who we areWe 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 treatment of diseases that threaten people and animals around the world.What we look forImagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.#HYDIT2025Required Skills: Asset Management, Audit Preparations, Benefits Management, Business Administration, Business Analysis, Business Management, Documentation Compliance, Internal Audit Controls, IS Audit, Management System Development, Manufacturing Compliance, Pharmaceutical Guidelines, Pharmaceutical Management, Pharmacovigilance, Product Management, Regulatory Requirements, Requirements Management, Stakeholder Relationship Management, Strat