Experience Drug Safety Revenue

About Experience Drug Safety

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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