Advanced Certificate Course in Pharmacovigilance and Clinical Data Management

The Advanced Certificate Course in Pharmacovigilance and Clinical Data Management at IHS, Varanasi, offers intensive training on two critical pillars of the pharmaceutical industry—ensuring drug safety and managing trial data with accuracy. The pharmacovigilance module covers global drug safety regulations, adverse drug reaction (ADR) reporting, signal detection, case processing, risk management plans, and compliance with agencies like the US FDA, EMA, and WHO-UMC. The clinical data management module trains participants in designing case report forms (CRFs), data validation, query resolution, database locking, and using industry software such as Oracle Clinical or Medidata Rave. Through practical assignments, simulated projects, and exposure to real-world case studies, learners gain the skills to work in pharmaceutical companies, CROs, regulatory authorities, and pharmacovigilance outsourcing firms.