No more applications are being accepted for this job
- MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
- The Drug Safety Data Manager will be responsible for development of SDTM, presentation of data in table and listing, and visualization for clinical safety monitoring as well as post-marketing reporting requirements.
- Apply SDTM dataset or Argus data to be used in visualization tool (SpotFire or Power BI) to visualize the output for safety analytics
- Create Drug Safety reports using safety reporting tool (IBM Cognos) which is a data mart of the Safety database (Argus)
- Develop and maintain systematic criteria and algorithm of selecting adverse event terms for the labelled or expected event and safety signal/risk and make them up to date along with the MedDRA version.
- Strong experience in using data management technologies (safety data system (e.g. Argus, Arisg), clinical data management systems, electronic data capture, data review tools, data warehousing)
- Experience in developing drug safety data management standards (CDISC, SDTM, ADAM)
- Demonstrate knowledge in research design, system validation, E2B / CDISC, standard coding dictionaries (MedDRA)
Manager, Drug Safety Data - Jersey City, United States - Mitsubishi Tanabe Pharma
