Experience Drug Safety
Pharmaceuticals - , ,
Experience Drug Safety Employees
Experience Drug Safety Senior Management
Experience Drug Safety Details
I can assist in the various activities common in PharmacoEpidemology/Drug Safety departments of Pharmaceutical Companies.Work can be done on location (depending on location...) or from my home office.Taks can be (but are not limited to):*Review of serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance* Quality control review of completed SAEs in various databases, or even data entry if needed.*Quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements*Preparing and/or reviewing Periodic Reports or Expedited Safety Reports for submission to Regulatory Authorities *Assisting in compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports*I am trained in the use of EVWeb, I have experience with electronic submission through EVWeb and WebTrader
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