募集要項
- 仕事内容
-
・Direct the operations of the Global Safety and Pharmacovigilance group in a region
・Provide managerial oversight of the Global Safety and Pharmacovigilance Group
・Provide regulatory consultation regarding safety reporting for investigational drugs
・Prepare documents describing the process for monitoring and reporting serious adverse experiences (e.g., SOPs, user manuals)
・Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting
・Act as project manager for stand-alone Safety and Pharmacovigilance projects
・Provide input to the overall processes, policies and procedures of the review and processing of safety information in the department
・Interact with clients and internal staff to provide advice and guidance on safety review issues; provide training and consultation to clients
・Identify training needs in pharmacovigilance and work with Training Group to implement appropriate training
他
- 応募資格
-
- 必須
-
◆Minimum Requirements
・Bachelor’s Degree in a life science or nursing
・Seven years of relevant pharmaceutical or clinical research industry experience
・Excellent knowledge of ICH guidelines and regulations relating to pharmacovigilance
・Prior management and supervisory experience
・Demonstrate working knowledge of MS Office applications
・Excellent verbal and written communication skills
・Ability and willingness to travel(～20％)
- 雇用形態
- 正社員
- 勤務地
- 東京
- 勤務時間
- 9:00～18:00（所定労働時間8時間）
- 年収・給与
-
想定年収：約900万円～1300万円
※経験・スキルにより会社規定により決定します。
※上記年収の他に、実績とPerfomance評価により業績賞与が別途支給されます
- 休日休暇
- ・年間休日120日以上 ・完全週休2日制（土日） ・祝日 ・年末年始 ・有休休暇 ・慶弔休暇 ・引越休暇 他
