Planning and implementing surveillances Managing operation of surveillances Cooperating with CROs and HOCs closely Managing surveillance as a therapeutic area Post Marketing Surveillance 1. Creating PMS basic and execution plans 2. Drafting CRFs for PMS 3. Implementing PMS 4. Oversee the development, implementation and enforcement of PMS, including data collection, analysis and summary of results. 5. Educating sales staffs regarding PMS 6. Creating and reviewing a J-PSUR (surveillance part) 7. Establish proper collection of safety information from HOCs. 8. Creating and review answer to inquiry which will be submitted to the Japanese Regulatory Authority. 9. Prepare and revise local SOP related and PMS(GPSP). 10. Contribute to establish and maintain good relationship with regulatory agency 11. Continuously improve overall work process Cooperation with CRO 1. Selection of CRO 2. Managing CRO's operation 3. Auditing CRO's operation 4. Requesting improvement of CRO's operation, if needed. 1. Support development of strategic plans for safety differentiation of BMS KK product. 2. Plan and implement training of BMS KK staff on PMS. Reporting Relationship Report (at a minimum )to: Senior Manager(EG-130), PMS Management , Patient Safety-Japan 1. 2. 3. Ability of time management 4. Ability of CRO management 5. 6. Presentation skills(effective presentations in and outside the Company) 7. Negotiation skills with the Company and external parties. 8. Assist Senior Manager(EG-130) Over 8 years of experience in PMS or related work experience. Experience of re-examination applications and its inspections (twice or more are preferable).