Mopus Bridge Rd & Ridgebury Rd Ridgefield, CT 06877
- Directly responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOPs, local working instructions and local regulatory requirements.
- Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations.
- Serve as point of contact with clinical team in areas of adverse events process.
- Assist with collection, processing, and reporting on adverse event reports.
- Pharmaceutical Industry experience. Must possess solid understanding of federal regulations as they apply to drug surveillance for both IND and NDA reporting.
- Strong communication skills required in order to facilitate report preparation, participate in working groups and interact with a variety of departments.
- Experience with computerized data entry and retrieval as well as other computer-based applications (word/excel) is also required.
- Bachelor’ s Degree in biomedical science or equivalent and a basic knowledge of clinical medicine
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.