【Janssen】R&D: Group Manager, Risk Management Group, Safety Risk Management Dept.

Application Due Date: 2021/10/25 JOB SUMMARY Oversee the safety risk management activities from investigational phase through post-marketed phase including the preparation and implementation of risk management activities of Janssen Japan portfolio and products such as risk assessment and risk minimization planning within responsible therapeutic area. Plays a diverse role in developing motivated people who will be a successor of this position and manage responsible teams or groups including task forces. KEY RESPONSIBILITIES: Oversee all safety risk management activities from investigational phase through post-marketed phase including J-RMP development, EPPV implementation, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Unlisted non-serious aggregate ADR report within responsible therapeutic area under GVP. Oversee all PMS activities such as J-RMP from PMS point of view, protocol, case report forms, J-PSURs, every regulatory reports/dossier created based on PMS data and regulatory correspondences associated with GPSP, GPSP inspection within responsible therapeutic area. Strives for excellence in work of J-RMP related activities including PMS through engagement with Janssen Japan’s key stakeholders, Global Medical Safety and Global Medical Affairs within responsible therapeutic area. Develops near and midterm plans for all relative activities for not only project activities, but also non-project activities, conducts resource management and people development, implements the plans and monitors effectiveness of the plans with good quality standard as well as compliances, collaborated with Director. Liaises with the key stakeholders in BU and related function such as R&D, MAF, IMAT within responsible therapeutic area. Approves and monitors department budgets and controls expenditures, collaborated with Director and relevant functions within JSS. Deliver JRML, PVA and PMS-O who have ability to fulfill the accountabilities and/or responsibilities described in their respective Job Description. Qualifications <Experience/Knowledge> 8-year or more experiences in pharmaceutical industries are generally recommended. Experience in a cross cultural/global environment necessary <Skills/Capabilities> Strong managerial skills and communication skills necessary. Ability/competency to show contentious proposals to subordinates. English communication skill (TOEIC 700 point and above), verbal, writing, presenting and facilitating. <Qualification/Certificate> BA in a biological or medically related field is preferred Primary Location Japan-Tokyo-To-Chiyoda- Organization Janssen Pharmaceutical K.K. (7195) Job Function R&D Requisition ID 2105977838W