Case Processing Staff Japan

Case Processing Staff Japan

YOUR TASKS AND RESPONSIBILITIES :

• Promptly and accurately identify, interpret and extract adverse event and all relevant corresponding case information from a wide variety of source documents
• Enter the extracted information into the global database for serious and non-serious AE / ADR case reports
• Identify information such as product technical complaints in the source documents, which must be further processed by the local affiliate, and forward accordingly
• Adhere to internal data entry standards and specific timelines as prescribed by global regulations and SOPs
• Create and review comprehensive medical case narratives with no important gaps regarding the reported information received
• Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name)
• Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology
• Perform assessment of cases regarding the global listedness
• Enter drug-event relationship in non-serious and serious expected ADR / AE case reports as per company policies
• Ensure medical plausibility, consistency and completeness of ADR case reports and appropriate case level status with regard to regulatory agency reporting
• Request follow-up information for the completion of case reports making use of specific product / event-related questionnaires when necessary. Consult medical experts within TA group for advice in clinical questions
• Regularly monitor the lists in scope for Japan case processing and perform the following actions as deemed appropriate : expedite the handling of high-priority cases, inform the team for awareness and cooperation, prepare and coordinate the process, and escalate to managers
• Perform case quality control activities in accordance with company internal standards
• Perform regular quality data analysis and identify quality issues related to source documents and data entry, need for alignment or need for additional guidance related to case processing topics
• Prepare and conduct training on case processing topics of interest
• Support training and mentoring activities as requested
• Serve as mentor for new PV Case Processors
• Contribute to a continuous improvement of PV system and processes

WHO YOU ARE :

WHAT BAYER CAN OFFER YOU :

ASAP 部門 : 医療用医薬品 勤務地 : 日本 : 大阪府 : 大阪府 職務領域 : メディカルアフェアーズ＆ファーマコビジランス ポジションの職務等級 : E11 to E12 社員区分 : 正社員 勤務時間 : 09 : 00 - 17 : 30 連絡先 E-Mail recruiter_jp@bayer.com