・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.
・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 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.
・University degree or above
・At least 4 years in a pharmacovigilance (PV) role and at least 2 years in a case
・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 Language and business level Japanese skills (N2 or above)
・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
Japan & Chinaの代表として広い視野を持ってご活躍頂けるポジションです！グローバルに直接レポートとなり、インターナショナルな環境で将来的なキャリアパスの可能性も広げていただけます。ご興味がございましたら、是非お気軽にお問い合わせください。