Specialist GxP Product Analysis Pharmacovigilance IT
Hyderabad, Telangana, India · Hybrid
Mid level
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Skills: Pharmacovigilance, GxP Compliance, Business Analysis, SDLC Documentation, Requirements Management
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Full-time
Posted 51d ago
Apply by Jun 26
~40 hrs/week
Responsibilities
The role involves partnering with business stakeholders to translate regulatory and business needs into clear system requirements for Pharmacovigilance IT solutions. The analyst is responsible for maintaining GxP-compliant SDLC documentation and supporting the full lifecycle of PV systems, including validation and optimization.
Requirements
Candidates need 3-5 years of experience with PV applications and a strong understanding of pharmacovigilance business processes. Proficiency in authoring SDLC/validation documentation for GxP systems and managing stakeholder communications is required.
Full job description
Job Description
Pharmacovigilance (PV) IT Product Analyst
The Opportunity
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.
Who we are
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 treatment of diseases that threaten people and animals around the world.
What we look for
Imagine 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.
#HYDIT2025
Required 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, Strategic Planning, System Designs
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/26/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
Animal FeedVeterinaryHealth CareData ManagementBiopharmaClinical TrialsBiotechnologyMedicalPharmaceuticalData Center Automation
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
Animal FeedVeterinaryHealth CareData ManagementBiopharmaClinical TrialsBiotechnologyMedicalPharmaceuticalData Center Automation