Case Processing Staff Japan
今すぐ応募する »日付: 2024/08/24
場所: 大阪府, 大阪府, JP
会社: Bayer AG
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Case Processing Staff Japan |
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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 advicein 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 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
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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: | E11-12 | |
社員区分: | 正社員 | 勤務時間: | 09:00 - 17:30 |
連絡先 | ||
recruiter_jp@bayer.com |
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