Sandeep Kumar Email & Phone Number

10 years of work experience in Pharmacovigilance, currently working as compliance lead in Soterius INC. Previously worked with Syneos health, Cognizant, Kinapse, APCER, Wipro. M Pharm (Pharmaceutics)Currently working as project compliance lead, compliance management, trainer, client handling SOP and WI writing. Previously worked as Quality control of ICSRs in Argus for case processing of spontaneous, patient support program, market research program, non-interventional study, license partner, pregnancy, literature, regulatory authority, drug device combination products and other study cases for antiepileptic drugs, biological drugs for psoriasis, psoriatic arthropathy, osteoporosis, myasthenia gravis, diabetic drug domain. Working as subject matter expert (SME) for case processing team providing them guidance and query resolution. Providing mentorship to new associates on case processing convention on Argus as per client SOP guidelines, maintaining training compliance. updating all the fields in Argus, Medra coding of events case assessment, labeling, Narrative generation and case correction, query generation for taking follow-up of patient information in Argus.Worked on EMA-CP case processing of ICSR for regulatory authority on EVWEB for Covidvaccines for EU countries. Quality control of ICSRs under EMA Data Management Process in which ICSRs submitted to the regulatory has been thoroughly check for each section (Patient identifier, Drug, Event, Lab test, Reporter, Narrative, Medra coding of event) and correcting the ICSRs if required and providing report of quality ICSRs to the EMA.Performed literature research and analysis of the data for other for Periodic safety update report(PSUR) and Signal detection.Data Entry in Art 57 database (Xevmpd database) in Eudravigilance for EU clients. Update ofSmPC, withdrawal of products from Xevmpd database, update of New Grant of products invarious EU countries in Xevmpd database.Literature monitoring of Embase and Pubmed searching database for the identification of validand Potential ICSRs and using this data for the scientific and business research maintenance ofcompliance for all EU clients for submitting products as per regulatory guidelines inEudravigilance database.

Listed skills include Research Associate Formulation Development, Good Knowledge Of Argus Software For Pfizer Process For Us, and Good Hand On Ms Office.