Company OverviewPharmaceuticals Company
Job Description1. Ensure case processing activities and case submission to Global Case Management and PMDA within reporting timeline
2. Ensure dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with COJ
3. Set up case processing process for clinical trials including consultation with PMDA and coordination with CRO
4. Maintain PV database including system update according to strategy and international regulation
Requirements・ Bachelors Degree
・ Medicine Major
・Japanese Native is highly preferable
・English：TOEIC score: more than 800
・More than 15 years’ experience in working in PV function.
・More than 5 years’ experience in managing people.
・Experience in managing CRO is preferable.