Drainage Design Engineer

Location Work from Office ( Bangalore or Thane)

Educational experience required: Life-science graduate

Minimum experience required: 2 years

Experience in post marketed and clinical trial ICSR Regulatory Reporting or any kind or Regulatory Submissions

Experience of determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence .

Knowledge about concepts of post market and clinical trial reporting ICH E2A and 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 submissions, courier and manual email submissions of CIOMS, MEDWATCH.

Experience in ICSR regulatory submission and regulatory guidelines for drugs, biologics, combination products for various countries.

Knowledge of FDA guidance on Drugs and combination products, VAERS system and EMA biologics guideline, GVP VI will also be helpful.

Knowledge of automated and manual scheduling of regulatory reports in safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report.

Additional experience in case processing in Argus is additional benefit. Should have adequate exposure of processing various types of cases like solicited, literature, spontaneous