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
• Contribute to a continuous improvement of PV system and processes
• 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

WHO YOU ARE:
 

• Bachelors degree or above in life sciences 
• Prefer the candidate to have at least 2 years of Pharmacovigilance experience
• Prefer someone who has case processing experience 
• Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rules
• Should have or quickly develop basic knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and procedures in the major countries
• Should have or quickly develop good understanding of AE and drug coding conventions (MedDRA, WHO-DD).
• Basic knowledge of standard office software packages (Word, Excel)
• High sense of responsibility and accountability and special sense for diligence even for routine processes
• Proactive behavior and ability to keep timelines
• Well established interpersonal skills. Excellent oral and written communication skills are essential
• Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology
• Should possess well established decision-making and organizational skills, along with practiced training skills
• Most important competences are drives results and manages complexity
• Should possess or quickly develop the ability to establish cooperative working relationships with staff from different cultural and medical backgrounds 
• Fluency in English verbally and in writing (TOEIC 700+ is desired ) and Japanese
• Must be able to fluently communicate with colleagues from PV data entry sites in other countries