Case Processing Staff

Company Overview
欧州系企業らしい穏やかな雰囲気が魅力の同社。グローバルにおける日本のプレゼンスが高く、良好な関係が築けているため、各部門でグローバルへの異動やShort-time assignmentの実績があります。
本ポジションもグローバルと距離が近く、部門長も外国籍の方となるため、英語に抵抗がない方を募集しております。チームメンバーも海外経験がおありの方が複数いらっしゃいます。
面接官となる方からも直接詳細をお伺いしておりますので、お気軽にお問い合わせください。

Job Description
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

Requirements
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 knowledgeof 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

Additional Job Information
• Leadership：勝つためにプレーする/Play to win
• Integrity：信頼を築き、インクルーシブである/Build trust and be inclusive
• Efficiency：無駄なく、迅速に/Be lean and fast

日本大阪 地図