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 documentsEnter the extracted information into the global database for serious and non-serious AE/ADR case reportsIdentify information such as product technical complaints in the source documents, which must be further processed by the local affiliate, and forward accordinglyAdhere to internal data entry standards and specific timelines as prescribed by global regulations and SOPsCreate and review comprehensive medical case narratives with no important gaps regarding the reported information receivedVerify, 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 terminologyPerform assessment of cases regarding the global listednessEnter drug-event relationship in non-serious and serious expected ADR/AE case reports as per company policiesContribute to a continuous improvement of PV system and processesEnsure medical plausibility, consistency and completeness of ADR case reports and appropriate case level status with regard to regulatory agency reportingRequest 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 someone who has case processing experience Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rulesShould 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 countriesShould 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 processesProactive behavior and ability to keep timelinesWell established interpersonal skills. Excellent oral and written communication skills are essentialMust possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminologyShould possess well established decision-making and organizational skills, along with practiced training skillsMost important competences are drives results and manages complexityShould 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 JapaneseMust be able to fluently communicate with colleagues from PV data entry sites in other countries

 

 

WHAT BAYER CAN OFFER YOU:　

 

We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at BayerWe provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your managerWe support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participationsAt Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employeesWe provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance

 

 

 

 

  採用予定日: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