Seenam Sharma

Background

About Seenam Sharma

A qualified healthcare professional, holding a degree of Bachelor of Dental Surgery with about 4.5 years of experience in Pharmacovigilance and more than 1 year of experience as a dentist •Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) with focus on clinical trial cases •Performed Triage and Data entry of ICSRs in the safety database, including writing clinical narratives. MedDRA coding, case processing, determining the expectedness of adverse events against various labelling documents and Quality review •Strong knowledge of ICH, GCP, GVP, US-FDA, Health Canada, MHRA, EMA and TGA safety reporting requirements •Experienced in maintaining a good knowledge of the safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations •Performed quality checks of ICSRs to ensure high quality of the reports in accordance with client SOPs and regulatory requirements •Extensive hands on experience with coding dictionaries including Meddra and WHO drug dictionary •Trained in audit preparation, CAPA investigations and program compliance •Knowledge and hands on experience on Argus Safety database •Experienced with electronic data capture systems including medidata Rave and Oracle Clinical remote data capture (OC RDC)