Niharika Mathur is an experienced Pharmacovigilance (PV) and Medical Writing Professional. Niha joined Fiore Healthcare Advisors in 2016 as a Freelance Consultant. Niha offers more than 7 years Safety experience that spans all aspects of PV system design and implementation, including process design and mapping, standard operating procedure authoring, and safety database implementation.
A graduate from The Institute of Clinical Research in India, Niharika has worked with pharmaceutical companies and Clinical Research Organizations (CROs) around the world. Her responsibilities within these organizations include processing, Quality Control (QC) and submission of Individual Case Safety Reports (ICSRs) to health authorities (paper and electronic) and authoring and QC of aggregate reports.
While working with a UK based PV service provider, Niha undertook a project to register clients, Sponsors and Marketing Authorization Holders (MAHs) with the EU health authorities for submission of electronic ICSRs via Eudravigilance. She was responsible for describing the procedure for registration in the Work Instruction and was also responsible for compiling a regulatory intelligence document that thoroughly outlined requirements for registration with health authorities and rules for reporting safety information for drugs and devices.
Furthermore, Niha has worked with databases like Argus, ArisG, Clintrace, and AERS for PV data collection and analysis. As a PV subject matter expert, she supported successful implementation of Argus safety suite. She has applied these skills by becoming both an Argus and ArisG Instructor and by moreover taking on a broader role as an Instructor in overall PV.
In addition, Niha is also a member of the European Medical Writers Association (EMWA).