<ul><li>Experience in post marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions.</li><li>Experience of “determining and assessing ICSR report ability to various regulatory authorities based on appropriate regulatory intelligence”.</li><li>Knowledge about concepts of post market reporting ICH E2D should be beneficial on cross reports across licenses of a pharmaceutical product.</li><li>Experience in ICSR regulatory submission and regulatory guidelines for vaccines for various countries. Knowledge of FDA guidance on Vaccines, VAERS system and EMA Vaccine guideline, GVP VI will also be helpful.</li></ul><p><br></p>

Operations Specialist - Regulatory Reporting