Senior Safety Technology Analyst

Parexel; India; Remote; INR 1,800,000 - 2,800,000; Full time

Job summary

Parexel International is seeking a Senior Safety Technology Analyst to drive the strategic implementation and operational excellence of pharmacovigilance safety technology systems. You will collaborate with Safety Operations, IT, Quality Assurance, and external auditors to ensure regulatory compliance, system optimization, and advanced safety solutions.

You will lead complex technology solutions, manage integrations, and guide change management while contributing to a growth-oriented environment

Qualifications

• 5+ years hands-on experience with safety applications across functional areas and secondary tools.
• Experience collaborating with safety operations teams to gather requirements and deliver technology solutions.
• Advanced knowledge of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP).
• Strong technical writing capability and ability to communicate complex concepts clearly to diverse audiences.

Responsibilities

• Lead the setup, configuration, and support of Parexel's safety database and related systems for new studies and ongoing operations.
• Coordinate safety database handovers from clients to Parexel and vice versa at project completion.
• Design and deliver complex integrations between Parexel safety technologies and other applications.
• Represent Safety Technology Management in cross-functional collaboration with IT, QA, and external auditors.
• Lead change management efforts in line with SDLC, including impact assessments, testing, and validation.
• Develop and deliver presentations and technical documentation for safety technology solutions.
• Lead issue resolution with IT, vendors, Safety Services staff, and clients for timely closures.
• Train and mentor team members in system administration, database support, and implementation activities.
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure regulatory compliance of safety systems.

Skills

Pharmacovigilance

System administration

Regulatory compliance

Stakeholder engagement

Leadership

Education

B.E./B.Tech or equivalent in Engineering/Computer Science

Tools

Argus

Vault Safety

EDC

Safety ERP

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart(R).

About the Role

We are seeking a Senior Safety Technology Analyst to join our team. As a Senior Safety Technology Analyst, you will drive the strategic implementation and operational excellence of Parexel's pharmacovigilance safety technology systems. This position plays a critical role in ensuring regulatory compliance, system optimization, and the delivery of advanced safety solutions that protect patient safety and accelerate clinical research. You'll collaborate with cross-functional teams across Safety Operations, IT, Quality Assurance, and external auditors, following industry-standard processes and regulatory frameworks. Responsibilities include designing and implementing complex technology solutions, managing system integrations, leading change management initiatives, and providing expert guidance on safety database platforms and emerging pharmacovigilance technologies.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing patient safety, driving operational excellence, and shaping the future of clinical research technology. With diverse teams and continuous learning opportunities, the Senior Safety Technology Administrator can explore career paths and expand skills across clinical research technology, regulatory compliance, and strategic system implementation.

Key Responsibilities

• Lead the setup, configuration, and support of Parexel's safety database and associated systems, including new study implementations, periodic and ad-hoc report generation, expedited report rule configuration, and comprehensive end-user support
• Direct the planning and execution of safety database handovers from clients to Parexel and from Parexel to clients at project completion, ensuring seamless transitions for complex pharmacovigilance operations
• Design and deliver complex integration solutions between Parexel safety technologies and other applications to enhance operational capabilities and drive service excellence
• Represent Safety Technology Management in cross-functional collaboration with IT, Quality Assurance, and external auditors, ensuring compliance with regulatory requirements, security standards, and quality protocols
• Lead change management initiatives aligned with Software Development Life Cycle principles, including impact assessments, testing methodologies, system validation, and software updates
• Develop and deliver presentations and technical documentation for safety technology solutions, including authorship and review of standard operating procedures and controlled documents
• Lead issue resolution and collaboration with Parexel IT, vendors, Safety Services staff, and clients for proper analysis and closure of technical issues across supported systems
• Train, coach, and provide work directions to team members in system administration, database support, and strategic implementation activities
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure safety systems maintain regulatory compliance and proactively meet evolving requirements

You’ll thrive in this role if you bring:

• Advanced technical expertise in pharmacovigilance safety technology systems, including complex configurations, system administration, and application support
• Exceptional interpersonal, verbal, and written communication skills with the ability to engage stakeholders at all levels
• Advanced analytical and problem-solving capabilities with a client-focused approach
• Strong leadership presence with the ability to mentor team members and represent the organization in cross-functional environments
• Demonstrated experience in system validation, change management, and regulatory compliance (21 CFR Part 11, EMA Annex 11, GAMP)
• Proficiency with standard scripting languages (SQL), Service Desk Tools, and project management methodologies
• Knowledge of emerging pharmacovigilance technologies, including AI, with a flexible attitude toward continuous learning and new challenges
• Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements

Required Qualifications

• 5+ years of hands-on experience with safety supportive applications (Argus, Vault Safety, EDC, Safety ERP) across all functional areas and secondary tools
• 5+ years of experience working closely with safety operations teams to manage issues, gather requirements, and deliver technology solutions
• Advanced knowledge and practical application of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP)
• Demonstrated proficiency with standard scripting languages (SQL) and industry-standard Service Desk Tools
• Strong technical writing capability and proven ability to communicate complex concepts clearly to diverse audiences

Preferred Qualifications

• BA/BSc in Engineering, Computer Science, or related field; master's degree preferred
• 1+ years of direct mentorship, training, or peer oversight experience
• Demonstrated lead participation in system/process improvement initiatives and 1+ years of system validation design and execution

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.