Senior Safety Technology Analyst

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee the establishment, configuration, and support of Parexel's safety database and related systems.

• Introduce new studies, create periodic and ad-hoc reports, configure expedited reporting rules, and offer comprehensive support to end-users.

• Manage the transition of safety database responsibilities between clients and Parexel at the beginning and end of projects.

• Design and implement integrations between Parexel's safety technologies and other applications.

• Act as a representative for Safety Technology Management in discussions with IT, Quality Assurance, and external auditors.

• Ensure adherence to regulatory standards, security protocols, and quality guidelines.

• Lead change management initiatives in accordance with Software Development Life Cycle principles, involving impact assessments, testing, system validation, and software upgrades.

• Create presentations and technical documentation, including standard operating procedures and controlled documents.

• Direct the analysis and resolution of technical issues in collaboration with IT, vendors, Safety Services personnel, and clients.

• Mentor, coach, and guide team members in their work.

• Work alongside the Global Pharmacovigilance Intelligence Office to ensure regulatory compliance and respond to evolving requirements.

⛳️ Requirements

• A minimum of 5 years of practical experience with safety supportive applications (such as Argus, Vault Safety, EDC, and Safety ERP) across all functional areas and related tools.

• Over 5 years of experience in close collaboration with safety operations teams to manage challenges, gather requirements, and provide technological solutions.

• In-depth knowledge and practical understanding of computer system regulations and guidelines (including 21 CFR Part 11, EMA Annex 11, GAMP).

• Proven expertise in standard scripting languages (SQL) and familiarity with industry-standard Service Desk Tools.

• Strong technical writing skills and a demonstrated ability to articulate complex concepts clearly to a variety of audiences.

• Advanced technical knowledge of pharmacovigilance safety technology systems, including intricate configurations, system administration, and application support.

• Excellent interpersonal, verbal, and written communication abilities.

• Advanced analytical and problem-solving skills.

• Strong leadership presence with the capability to mentor team members.

• Proven experience in system validation, change management, and adherence to regulatory standards.

• Knowledge of emerging pharmacovigilance technologies, including artificial intelligence.

• Comprehensive understanding of pharmacovigilance roles, standards, practices, GVP, and GCP requirements.

• Preferred: 1+ years of direct mentorship, training, or peer supervision experience.

• Preferred: Demonstrated leadership participation in system/process improvement initiatives and 1+ years of experience in system validation design and execution.

• Preferred: BA/BSc in Engineering, Computer Science, or a related field; a master's degree is preferred.

🏝️ Benefits

• Flexibility and the opportunity to excel in your work.

• Continuous learning opportunities available.

• Career advancement prospects in clinical research technology, regulatory compliance, and strategic system implementation.