Aarti Verma

-About nine years of industry experience in Drug Safety operations roles (oversight of CRO, managing adverse event reporting team, literature review, reconciliation, triage, generation of descriptive patient narratives, quality control, coding, regulatory submissions and EudraVigilance account management) -Experience in both clinical and post marketing products, phase I-IV studies in various therapeutic areas supporting risk management (chair Safety Review Team meetings, lead data analyses for identification of safety signals and generating safety reports for SMC/regulatory authorities) -Experience leading end-to-end safety operations for assigned studies, from study start-up to database lock (Safety Lead representing at Global project, Kick-off, Investigator meetings, design and execute processes as per Global Safety Plans) -Active contribution to inter-departmental aggregate/periodic safety reports, Protocol, IB, and ICF; review FDA End of Phase II Briefing package, DSUR, PBRER, Risk Management Plan -Lead department initiatives (mentoring/training, CRO/vendor management, finance/budget projection and approval, process design, compliance/QA management, author SOPs/Business practices) to support organization growth and operational excellence -Experience in Safety/Clinical databases (ArisG, Argus, Medidata, EDC, etc.), and Certified MedDRA coder -Three years clinical experience as a staff nurse in various specialty areas including NICU, adult medical/surgical, and pediatrics in the US; and as Homeopathic Physician in India