Safety Reporting Specialist

📋 Description

• Receive, prepare, and submit expedited and periodic safety reports to regulatory authorities
• Monitor safety report submissions, maintain accurate submission records, retain proof of
• Support compliance with global safety reporting requirements, regulatory guidelines, internal
• Prepare, organize, maintain, and archive regulatory submission files, ensuring documentation is
• Provide operational support to project leads, coordinate safety reporting activities, and
• Collaborate with internal teams and stakeholders to coordinate reporting tasks, resolve operational

🎯 Requirements

• Bachelor's degree or equivalent qualification with relevant academic or vocational training.
• Approximately 0-2 years of experience in safety reporting, pharmacovigilance, clinical research
• Basic understanding of medical terminology and ability to work accurately with clinical and
• Basic familiarity with procedural documentation and global safety reporting requirements, including
• Understanding of safety report preparation, submission tracking, regulatory documentation, and
• Proficiency in Microsoft Office applications (documentation, spreadsheets, reporting) and basic

🎁 Benefits

• Fully remote work from India.
• Structured Monday-to-Friday working schedule.
• Career development opportunities in safety reporting, pharmacovigilance, regulatory compliance, and
• Learning opportunities: exposure to global safety reporting requirements, regulatory submissions
• Collaborative environment with experienced project leads and cross-functional teams in an
• Meaningful contribution to patient safety and quality of clinical research and healthcare services.