I've supported drug safety operations at Accenture, processing Individual Case Safety Reports from clinical trials and spontaneous reports within FDA, EMA, and ICH timelines.
At Divis Pharmaceuticals, I maintained SOPs, analytical reports, stability documentation, and laboratory records while performing qPCR assays, aseptic testing, and real-time and accelerated stability studies. I also developed an electronic tracking system for working standards that improved inventory management and reduced retrieval time.
I'm experienced in collaborating with QA, QC, Manufacturing, and R&D teams to support compliant pharmaceutical quality and safety activities.
