Senior Expert – Pharmacovigilance IT Systems Specialist
Location: Bangalore
Job Type: Full-Time
Department: Pharmacovigilance Services
Experience Required: 10+ years in drug safety database systems and pharmacovigilance IT environments
Job Overview
The Senior Expert – Pharmacovigilance IT Systems Specialist is responsible for supporting, maintaining, and optimizing pharmacovigilance technology platforms to ensure regulatory compliance, system performance, and data integrity. This role focuses on enhancing drug safety systems, managing safety databases, and implementing technology-driven improvements aligned with global regulatory requirements.
The position requires strong expertise in pharmacovigilance IT infrastructure, system validation, and safety data lifecycle management. The specialist will collaborate with cross-functional teams to implement system enhancements, manage system changes, and ensure operational efficiency of safety platforms that support global healthcare and regulatory operations.
Key Responsibilities
Pharmacovigilance System Management
Support, maintain, and enhance pharmacovigilance systems to ensure compliance with global regulatory standards.
Lead implementation and continuous improvement of drug safety databases to maintain data integrity and operational efficiency.
Configure and optimize safety database systems to support evolving business requirements and organizational growth.
Ensure system functionality aligns with regulatory and compliance frameworks.
System Lifecycle and Process Optimization
Manage the complete lifecycle of pharmacovigilance system changes, including implementation, validation, and maintenance.
Drive continuous improvement initiatives for safety systems and processes.
Support integration of new technologies and digital solutions within pharmacovigilance operations.
Ensure adherence to software validation standards and system governance practices.
Regulatory Compliance and Data Integrity
Ensure compliance with global pharmacovigilance regulations and guidelines, including GxP requirements.
Maintain documentation, audit readiness, and data governance standards for safety systems.
Support validation activities in line with established software quality and regulatory frameworks.
Stakeholder Collaboration and Technical Support
Serve as a primary point of contact for system users, technical teams, and external vendors.
Collaborate with cross-functional teams to implement system upgrades and process improvements.
Provide technical guidance and training to system users and stakeholders.
Support service delivery and vendor management activities where required.
Project and Operational Support
Participate in IT project management initiatives related to pharmacovigilance systems.
Support system performance monitoring and issue resolution.
Contribute to strategic planning and system enhancement initiatives.
Educational Qualifications
University degree in Information Technology, Computer Science, or a related discipline.
Equivalent technical qualifications or relevant professional experience may be considered.
Experience Requirements
Minimum 10+ years of experience working with drug safety database systems within pharmaceutical companies, healthcare organizations, or software solution providers.
Demonstrated experience in pharmacovigilance systems management and safety data lifecycle processes.
Required Skills and Competencies
In-depth knowledge of pharmacovigilance systems, including safety database management and Life Science Master Validation (LSMV) processes.
Strong understanding of global drug safety regulations and compliance frameworks such as ICH, GVP, and GxP requirements.
Expertise in software validation methodologies and system validation frameworks including GAMP.
Strong organizational and analytical skills with the ability to manage multiple priorities.
Excellent written and verbal communication skills in English.
Strong collaboration and stakeholder management skills in global environments.
Ability to adapt to evolving business and regulatory requirements.
Preferred Qualifications
Experience in IT project management, service delivery management, or vendor management.
Experience supporting global pharmacovigilance operations in highly regulated environments.
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