Senior Safety Technology Analyst

🔥 12 hours ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧐 Analyst

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead the setup, configuration, and support of Parexel's safety database and associated systems • Implement new studies, generate periodic and ad-hoc reports, configure expedited report rules, and provide comprehensive end-user support • Direct safety database handovers between clients and Parexel at project start and completion • Design and deliver integrations between Parexel safety technologies and other applications • Represent Safety Technology Management with IT, Quality Assurance, and external auditors • Ensure compliance with regulatory requirements, security standards, and quality protocols • Lead change management aligned with Software Development Life Cycle principles, including impact assessments, testing, system validation, and software updates • Develop presentations and technical documentation, including standard operating procedures and controlled documents • Lead technical issue analysis and resolution with IT, vendors, Safety Services staff, and clients • Train, coach, and provide work direction to team members • Collaborate with the Global Pharmacovigilance Intelligence Office to maintain regulatory compliance and address evolving requirements

🎯 Requirements

• 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 • Advanced technical expertise in pharmacovigilance safety technology systems, including complex configurations, system administration, and application support • Exceptional interpersonal, verbal, and written communication skills • Advanced analytical and problem-solving capabilities • Strong leadership presence and ability to mentor team members • Demonstrated experience in system validation, change management, and regulatory compliance • Knowledge of emerging pharmacovigilance technologies, including AI • Deep understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements • 1+ years of direct mentorship, training, or peer oversight experience (preferred) • Demonstrated lead participation in system/process improvement initiatives and 1+ years of system validation design and execution (preferred) • BA/BSc in Engineering, Computer Science, or related field (preferred); master's degree preferred

🏖️ Benefits

• Flexibility and space to do your best work • Continuous learning opportunities • Career development opportunities across clinical research technology, regulatory compliance, and strategic system implementation

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