Otsuka Pharmaceutical Companies (U.S.)
Saint Paul, MN, USA
Position Summary Serves as the key stakeholder and subject matter expert (SME) representing Medical review function in internal audits, and health authority inspections. Being available on-site for inspections, internal audit and critical business activities, including at short notice. Provides oversight of the safety profile of Otsuka products Leads the development and execution of medical review strategies for investigational and marketed products Provides strategic leadership of the Global Medical review function and collaborates with other PV functions, vendors and partners. Serves as a member of the Global Medical Safety (GMS) Leadership Team partnering closely with the GMS Head Meets routinely with product specific GPV team members and acts as principal liaison for medical review matters to engage with regulatory agencies on product safety issues. Key Job Responsibilities Represents GPV Medical Safety department from a...

