NIHARIKA MATHUR

MSc Clinical Research, MBA Marketing, BSc Zoology

Niharika Mathur is a pharmacovigilance quality consultant with over 15 years of experience across pharmaceutical companies, CROs, and PV service providers, with a focus on PV quality systems, regulatory compliance, and inspection readiness. She has supported organisations of varying sizes in building and strengthening their pharmacovigilance frameworks, from day‑to‑day safety operations to the design of robust governance and oversight structures.

Since 2015, Niharika has worked as an independent consultant, helping teams design risk‑based PV processes, implement practical compliance monitoring and CAPA frameworks, and prepare documentation and teams for health authority inspections. A particular area of interest for her is pharmacovigilance regulatory intelligence: she enjoys building structured RI workflows and processes that identify and highlight updates to PV guidance to support compliance.

Earlier in her career, she held operational and leadership roles in global organisations where she gained hands‑on experience in ICSR processing, aggregate reporting, clinical trial safety support, and safety database implementation and validation. This blend of operational and quality experience underpins her pragmatic, risk‑based approach to PV system design, vendor oversight, and continuous improvement in compliance.

Niharika holds an MSc in Clinical Research from Dr. M.G.R. Educational and Research Institute and an MBA in Marketing from Guru Jambheshwar University, as well as a BSc (Hons) in Zoology from Gargi College, University of Delhi. She is trained as an ISO 13485:2016 Quality Management System Lead Auditor through BSI and has completed Practical Pharmacovigilance Auditing training with the Research Quality Association (RQA).