Safety Technology Analyst

Job not on LinkedIn

🔥 8 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Logo of Parexel

Parexel

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

• Conduct setup and support activities for Parexel safety databases and associated systems • Configure new studies, generate periodic and ad-hoc reports, configure expedited report rules, and provide comprehensive end-user support • Support safety database handovers from clients to Parexel and from Parexel to clients at study closeout • Contribute to standard operating procedures and controlled documents for safety technology systems • Support integration solutions between Parexel safety technologies and other applications • Represent Safety Technology Management with cross-functional teams and external auditors • Ensure adequate management of database systems, hardware, network security, quality standards, and project services • Collaborate with IT, vendors, Safety Services staff, and clients to analyze, resolve, and close technical issues • Support change management, impact assessments, testing, system validation, and software updates according to SDLC standards • Provide training and mentoring to new or developing staff • Ensure adherence to pharmaceutical regulations, including 21 CFR Part 11, computer system validation, and quality standards

🎯 Requirements

• Intermediate system administration and application support skills in pharmacovigilance safety technology, including safety databases, gateway/E2B, report development, or signal detection • Intermediate technical writing capability and experience with industry-standard Service Desk Tools • Analytical and problem-solving skills with a client-focused approach and strong attention to detail • Experience with software development lifecycle (SDLC) processes, change management, and Agile methodology • Knowledge of 21 CFR Part 11, EMA Annex 11, and GAMP guidelines • Intermediate knowledge of pharmacovigilance roles, standards, practices, GVP, and GCP • Intermediate SQL scripting skills • Interest in emerging pharmacovigilance safety technologies including AI • Flexible attitude toward work assignments, new learning, and ability to manage multiple tasks • 2+ years of experience in all functional areas of safety supportive applications, including Argus, Vault Safety, EDC, Safety ERP, secondary tools, and processes • 2+ years of experience working closely with operational teams to manage issues, gather requirements, and deliver safety business process solutions • Demonstrated experience with computerized system validation methodologies and processes • Fluent in English with demonstrated ability to write technical documentation and deliver clear presentations to stakeholders • Experience supporting team members through peer oversight, coaching, and training • BA/BSc in Engineering or Computer Science is preferred; master's degree or equivalent is preferred • Demonstrable participation in system or process improvement initiatives • Experience working with cross-functional teams as a safety technology representative

🏖️ Benefits

• Flexible work arrangements • Growth and continuous learning opportunities • Training and mentoring opportunities • Opportunity to work with emerging pharmacovigilance technologies • Contributions to clinical research and safety technology innovation

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