required skills. Determines eligibility for Spanish and English speaking patients for Medicaid, EMA and financial assistance programs...
, including expertise in the pharmaceutical sector, familiarity with FDA/CVM, USDA/CVB, EMA, VICH Guidelines, Clinical Field...
areas organized and records readily retrievable. Support internal/external audits (FDA, EMA, MHRA) by presenting chain...
., per FDA or EMA guidelines). Working knowledge of statistical analysis tools (e.g., GraphPad Prism, JMP, or Excel-based...
.• Knowledge of Athena, Epic, EMA EMR systems a plus.• Must have a valid driver's license and be willing and able to drive...
against applicable FDA, EMA, ATMP, and EU GMP Annex 1 expectations;translate identified gaps into risk-based remediation plans. Support.... Working knowledge of cGMP regulations, FDA and EMA expectations, data integrity, good documentation practices, and quality...
, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal detection methodologies, tools, and data...
and maintain a professional demeanor at all times. Some duties include reviewing medical documentation for accuracy, using EMA EMR...
for veterinary biologics and EMA / EU GMP standards. Automation: Experience with PLC/SCADA systems and data historians (e.g., AVEVA...
high-quality ICSR processing in accordance with company procedures, FDA regulations, ICH guidelines, EMA requirements...) reporting Individual Case Safety Reports (ICSRs) FDA safety regulations and submissions ICH guidelines EMA regulations...