Description:
This role performs Medical Review of ICSR's which include: - Independent submissions to the FDA and increased responsibility of adverse event reporting including quality control and medical analysis for both brand and generic products. -Medical Review involves a thorough review of each case utilizing advanced clinical interpretation of the case data to draw a causal relationship and the formulation of an accurate and complete medical opinion.Medical Reviews of ICSR's include post marketing products and investigational compounds. This position is responsible for providing oversight to vendors for data entry and processing activities. This can include but is not limited to writing medical opinions, submission to the Regulatory Authorities, conducting quality checks on vendor PV activities. This position ensures consistent and timely reporting of all Adverse events received by Amneal to the Regulatory Authorities, maintaining knowledge of and implementation of Pharmacovigi...