safety reporting (SAEs, SUSARs, MedWatch) and ensure timely submissions to IRB/FDA/sponsors per protocol and regulation...
, MedWatch) and ensure timely submissions to IRB/FDA/sponsors per protocol and regulation. Maintain accurate regulatory files...
and MedWatch communications where applicable. [fda.gov] Lead social media strategy and oversight in compliance with FDA’s Social...
MedWatch reports, notified body communications, and external notifications. Skills: Proven ability to independently...
records as appropriate;- Reports adverse events to the appropriate collector, such as MedWatch or a manufacturer...