Senior Safety Technology Analyst

Job not on LinkedIn

🔥 8 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🧐 Analyst

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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, 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 • Design and deliver complex integration solutions between Parexel safety technologies and other applications • Represent Safety Technology Management in cross-functional collaboration with IT, Quality Assurance, and external auditors • 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 standard operating procedures and controlled documents • Lead issue resolution and collaboration with Parexel IT, vendors, Safety Services staff, and clients • Train, coach, and provide work directions to team members • Collaborate with Global Pharmacovigilance Intelligence Office to ensure safety systems maintain regulatory compliance

🎯 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 • Advanced analytical and problem-solving capabilities with a client-focused approach • 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 • 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

🏖️ Benefits

• Flexible work arrangements • Growth opportunities • Continuous learning opportunities