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:

 

A degree in Pharmacy, Veterinary Medicine, Biology, Nursing, or another healthcare profession with a life science focus, or similar education with a medical or scientific emphasis, is preferable. Or at least 3 years of relevant experience in pharmacovigilancePrefer the candidate to have at least 2 years of Pharmacovigilance experiencePrefer 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
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 

 

 

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