Alka Bhardwaj

Background

About Alka Bhardwaj

Medical review of ICSRs, signal management (qualitative and quantitative), benefit risk assessment, medical review of aggregate reports, support rapid response team, support health authority queries. • Lead safety physician team - leading a global team of twelve drug safety physicians across US, EU, UK, Australia • People management includes hiring, training and mentoring safety physicians, functional management, drafting and review of medical safety processes, conventions, WIs, SOPs. • Literature review, review of RSIs (IB, SmPC, CCDS and other local labels). Update events for auto-labelling list for Argus data base • Support RMP review for NDA submission - safety specifications, and its identified and potentials risks, PV plan and risk minimization plans. • Medical analysis of safety data from different sources (safety database, data mining, literature, HA websites) to support qualitative and quantitative signaling management. • Review and support aggregate safety reports (DSURs, PSURs, PBRERs, PADERs), • Extensive clinical experience across specialties and therapeutic areas • Worked in close collaboration with principal investigators (PI) and medical monitors throughout patient care years. • Performed lab alert review, causality assessment. Participated in Clinical trials at the investigator site- Respiratory Medicine (for H1N1), pain medicine and devices (PCA device, automated bolus and lock alarm to avoid intentional opioid overdose during labor analgesia).