※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Case Processing Standards Senior Scientist
[Salary] 7〜11 million JPY ※Experiences and skills will be considered
- Provides significant contributions/reviews and provides suggestions for improvements to the Global Case Processing and the Japan China specific User manuals, User Letters, global SOPs, Operations Manuals, guidance documents and other global documents relating to adverse event case processing.
- Propose improvements for greater efficiency and solutions to problems relating to any aspect of case handling processes.
- Keep up-to date with changes in Pharmacovigilance legislation and work closely with the Case Processing Standards head in transferring these to the case processing guidance and training material.
- Provide guidance to Case Processing staff and timely answers to difficult case processing questions raised from PV Safety database users (6 our company's sites, 4 CRO offices)).
- Represent Case Processing Standards in Japan and China providing expertise/guidance to the large number of JP/CN staff involved with case processing.
- Translates compliance and quality control metrics, provides proposals for process improvements leading to enhanced compliance and increased efficiency. Respond to heath authority requests and deliver support during PV audits and PV inspections.
- Optional: Fulfill the additional role of SCP Trainer and support the definition of training requirements to ensure consistency and high-Key Tasks: quality case processing standards within reporting timelines. Create and maintain global training material for the SCP organization including delivery of Instructor Led trainings to internal as well as external staff in contract research organizations (CRO) in Japan and China for alignment with the SCP Training Lead.
- Act as a primary SCP liaison with other PV functions to work on special projects according to business needs arising from changing regulations or product portfolios. Provide expertise for all aspects of standardization and quality and ensure that agreed upon case procedures are efficient and compliant with global SOP/OI and global legal requirements.
- He/she is the key/sole representative of Case Processing Standards in Japan/China (at company, at CROs) providing expertise/guidance to the large number of JP/CN staff involved with case processing.
- At least 4 years in a pharmacovigilance (PV) role and at least 2 years in a case processing role
- Expert knowledge and understanding of PV case processing procedures, PV SOPs and procedures, PV global safety database, rules regarding case processing and knowledge of PV workflow processes, with ability to offer suggestions for improvements.
- Significant expertise regarding global pharmacovigilance regulations and guidelines on handling and reporting of individual case safety reports
- Track-record of process optimization activities and problem solving ability with attention to detail, good judgment and decision making.
- Optional: Experience in delivering training on PV database use and PV processes.
- Must have a confident attitude to guide/advise and train users of the PV Safety Database, including license partners and CROs.
- Excellent verbal and written communication skills in English.
- Excellent interpersonal skills of diplomacy and tact, knowledge and respect of cultural differences.
- High sense of responsibility and diligence even for routine processes
- Proactive behavior and ability to keep timeline
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, Quality Assurance