Operations Specialist 1 - Pharmacovigilance Regulatory Reporting

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 submissions, courier and manual email submissions of CIOMS, MEDWATCH.
• Experience in ICSR regulatory submission and regulatory guidelines for vaccines for various countries. Add on benefit. This would be specifically for Grade 140.
• Knowledge of FDA guidance on Vaccines, VAERS system and EMA Vaccine 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.

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