NIHARIKA MATHUR

MSc Clinical Research, MBA

Niharika Mathur is an experienced Pharmacovigilance and Medical Writing Professional, with over 8 years of safety experience spanning all aspects of PV system design and implementation, including process design and mapping, standard operating procedure authoring and safety database implementation.

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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 included processing, Quality Control (QC) and submission of Individual Case Safety Reports (ICSRs) to health authorities and authoring and QC of aggregate reports.

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As an example of her contributions, Niha lead a project to develop a process for registration of Sponsors and Marketing Authorization Holders (MAHs) with the EU health authorities Eudravigilance portals. She developed comprehensive compilations of regulatory intelligence documents related to registration and reporting obligations for drug and devices to facilitate, streamline and maximize compliance with such processes. 

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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 asuccessful 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.