Shimpi Singh

I’m a dedicated medical professional with 10+ years of experience in pharmacovigilance and medical review, focused on turning safety data into clear, compliant decisions. My strength is adverse event analysis across the full Individual Case Safety Report (ICSR) lifecycle—MedDRA coding, causality assessment, and medical review quality.

In my current roles, I’m responsible for quality checks, metrics maintenance, and SLA adherence while liaising with clients to resolve queries and discrepancies. As a backup team lead, I manage workflows and prioritize cases across multiple workflows to keep teams aligned and productive.

I also serve as a technical trainer and subject matter expert, developing and delivering induction/orientation programs for new starters and preparing training materials. I identify training needs across project teams, run train-the-trainer sessions, and provide refresher training and mentoring to accelerate integration.

Earlier in my career as a drug safety specialist and associate, I conducted thorough medical review and offline peer reviews, verified source-to-narrative consistency, performed SAE reconciliation, and supported audits/inspections for regulatory standards. I bring practical expertise with ARISg and Argus Safety databases, regulatory frameworks (ICH E2A/E2B/E2C, EMA GVP modules, FDA FAERS), and core quality processes (SDQC, CTV, PTAP, case transmission verification), recognized through awards including the Best ICSR Award and BPS Star Performer Award.