Safety Reporting Specialist

Accountabilities

Safety Report Preparation and Submission: Receive, prepare, and submit expedited and periodic safety reports to the appropriate regulatory authorities, clients, and other relevant parties, ensuring compliance with applicable regulations, country-specific legislation, and reporting timelines.
Submission Tracking and Documentation: Monitor all safety report submissions, maintain accurate submission records, and retain proof of submission. Promptly escalate potential delays, quality concerns, and reporting issues to the assigned lead or line manager.
Regulatory Compliance: Support compliance with global safety reporting requirements, regulatory guidelines, internal work practices, and client-specific standard operating procedures (SOPs).
Regulatory File Management: Prepare, organise, maintain, and archive regulatory submission files in accordance with established procedures, ensuring documentation is complete, accurate, accessible, and audit-ready.
Project Coordination: Provide operational support to assigned project leads, coordinate safety reporting activities, and contribute to the effective delivery of project milestones. Opportunities may include managing smaller projects independently.
Cross-Functional Collaboration: Liaise with relevant internal teams and stakeholders to coordinate reporting tasks, resolve operational questions, and ensure the timely exchange of information required for safety reporting activities.
Reporting Systems and Data Maintenance: Generate reports as required and maintain reporting systems and repositories with accurate, up-to-date contact details and relevant project information.
Metrics and Performance Reporting: Assist managers in collecting, consolidating, and validating project metrics to support performance monitoring, operational reporting, and continuous improvement.
Administrative Support: Provide additional administrative and coordination support to the safety reporting team as needed, helping maintain efficient workflows and reliable documentation practices.
Quality and Accuracy: Apply strong attention to detail when processing safety information, reviewing submission records, and maintaining sensitive data, ensuring that work meets established quality standards.
Requirements
Education: A bachelor's degree or equivalent qualification, supported by relevant academic or vocational training.
Professional Experience: Approximately 0–2 years of relevant experience in safety reporting, pharmacovigilance, clinical research, regulatory affairs, or a related field. Equivalent combinations of education, training, and directly relevant experience may also be considered.
Medical Terminology: Basic understanding of medical terminology and the ability to work accurately with clinical and safety-related information.
Regulatory Knowledge: Basic familiarity with procedural documentation and global safety reporting requirements, including relevant US Food and Drug Administration (FDA) regulations and guidelines.
Safety Reporting Knowledge: An understanding of safety report preparation, submission tracking, regulatory documentation, and reporting timelines is beneficial.
Systems and Software Skills: Proficiency in Microsoft Office applications, particularly tools used for documentation, spreadsheets, and reporting. A basic understanding of safety database functionality is also expected.
Communication Skills: Good written and verbal communication skills, with the ability to exchange information clearly, document activities accurately, and interact professionally with colleagues across different organisational levels.
Organisational Skills: Strong time management, prioritisation, and coordination abilities, with the capacity to manage multiple reporting activities and meet strict deadlines.
Attention to Detail: A careful and methodical approach to reviewing safety reports, validating records, maintaining documentation, and ensuring data accuracy.
Confidentiality and Professionalism: The maturity and discretion required to handle sensitive clinical, medical, and regulatory information responsibly.
Teamwork: Ability to collaborate effectively with project leads, colleagues, and cross-functional stakeholders while contributing to shared objectives.
Problem-Solving Skills: Ability to identify discrepancies, recognise potential reporting issues, follow established procedures, and escalate concerns appropriately.
Adaptability and Learning: Willingness to develop knowledge of pharmacovigilance processes, regulatory requirements, reporting systems, and clinical research standards in a structured professional environment.
Remote Work Readiness: Ability to work effectively in a fully remote position while maintaining productivity, accuracy, communication, and adherence to reporting deadlines.
Benefits
Fully Remote Work: Opportunity to work remotely from India.
Structured Working Schedule: Standard Monday-to-Friday working arrangement.
Career Development: Opportunity to build a career in safety reporting, pharmacovigilance, regulatory compliance, and clinical research.
Learning Opportunities: Gain practical exposure to global safety reporting requirements, regulatory submissions, and clinical research processes.
Collaborative Environment: Work with experienced project leads and cross-functional teams in an international life sciences setting.
Meaningful Contribution: Support activities that help maintain patient safety and the quality of clinical research and healthcare-related services.
Professional Growth: Develop project coordination, regulatory documentation, reporting, and quality management skills.
Inclusive Workplace: Access to a professional environment that values collaboration, innovation, accessibility, and equal employment opportunities.
Employee Accommodation Support: Reasonable accommodations are available for qualified individuals with disabilities during the recruitment process and when performing essential job functions.