Otsuka Pharmaceutical Companies (U.S.)

The Associate Director, Global Medical Review provides input into the medical review of safety data for investigational and marketed products. The role is responsible for ensuring high-quality medical review activities, consistency across internal and external reviewers, and compliance with global pharmacovigilance regulations and company procedures. The Associate Director serves as an expert contributor and subject matter expert resource within Global Pharmacovigilance, partnering with Medical Safety Product Leaders, PV Operations, Regulatory Affairs, Clinical Development, Quality, affiliates, and vendors to support patient safety. Demonstrate flexibility and responsiveness by being available on-site, when required, to support critical business activities, cross-functional engagements, audits, inspections, and regulatory interactions. Key Responsibilities Represents the Medical Review as subject matter expert during internal audits, partner audits, and health authority...