Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs
Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high- quality medicines.
Coordinate with production and PPIC team for Mfg. area allotment Execute technology transfer activities from R&D to manufacturing for formulation products, ensuring smooth scale-up and process transfer
Data entry of safety data onto adverse event database and tracking systems.Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role : Site-essential roles require 100% of shifts onsite at your assigned facility.
Support global regulatory lifecycle management activities across EU, US, and international markets. Contribute to regulatory strategy development for global and regional submissions