※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Case Management Manager／30代半ば〜40代半ばの方におススメ！
[Salary] 10〜12 million JPY ※Experiences and skills will be considered
- Organize, manage and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity
- Carry out all case management activities as appropriate
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Ensure complete and timely forwarding of ICSR to Core
- Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
- Consistently apply regulatory requirements and Company policies
- Analyze and monitor activities, define and implement corrective actions, where applicable
- Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
- Provide oversight and team mentoring on case handling aspects, data extraction and analyses
- Manage safety resources in the Case management
- Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the GPO DSU organization
- Act as subject matter expert for the DSU within WWS
- Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
- Promote/participate, as appropriate, in local, internal and external safety activities
- Health Care Professional or equivalent experience preferred
- Minimum 4 years' experience in pharmacovigilance and/or data management, clinical care or clinical or scientific research required
- Experience and skill with medical writing an advantage
- Ability to independently solve routine problems related to case processing and surface issues constructively
- Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
- Ability to discern when additional input is required to effectively address unique and/or complex situations
- Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals
- Ability to accomplish team goals by facilitating team members' contribution
- Demonstrated ability to foster teamwork
- Fluency in spoken and written English （TOEIC Score ≧ 730）
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Other, Quality Assurance