IQVIA Job Vacancies information 2021
Job Details :- Operations Specialist 1 – Pharmacovigilance Regulatory Reporting
Location: Bangalore, India
Knowledge & Experience:
• Minimum 2.6 to 5 years of experience in Pharmacovigilance
- Experience in post marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions
- Experience in post marketed case processing. Added advantage: Case processing of Vaccine cases, cases from Regulatory authorities and literature reports
- Knowledge of EVHUMAN case downloads and processing
- Experience of “determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence”.
- Knowledge about concepts of post market reporting ICH E2D should be beneficial on cross reports across licenses of a pharmaceutical product.
- Should have experience and knowledge of various formats of ICSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal ubmissions, courier and manual emaubmissions of CIOMS, MEDWATCH.