The enterprise risk management in pharmaceutical company

Abstract

Enterprise Risk Management (ERM) is a structured and holistic approach used by organizations to identify, assess, and manage the multitude of risks they face across all levels of operation. In the pharmaceutical industry, where innovation, compliance, safety, and quality are paramount, ERM plays a particularly vital role. Pharmaceutical companies operate in a high-stakes environment marked by regulatory scrutiny, global competition, long product development cycles, and significant investment in research and development. Given the complex interplay between clinical research, regulatory approvals, supply chain management, intellectual property, and market dynamics, the industry is inherently exposed to various risks that can threaten business continuity, financial performance, and public health outcomes.