Your Key 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.
About You:
- Bachelor's 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.
-
Osaka BayerCase Processing Staff Japan · Your Key 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 ...
-
Osaka Santen Full timeThe Global Process Lead in Master Data Management (MDM) is a critical role that oversees the design, implementation, and optimization of MDM processes across the organization. · This role involves working closely with business units, functional colleagues in the transformation pr ...
-
Osaka SBI生命保険株式会社 正社員■業務内容 · 従業員向けのユーザーサポート業務を中心にシステム運用をサポートしていただきます。従業員の生産性や社内セキュリティをプロセスやテクノロジーを使って向上させていくポジションです。 · ・社内ユーザーからの情報システムに関する問い合わせ対応 · ・IT機器管理 · ・各システムの定常業務対応(アカウント管理・本番作業等 設定業務) · ・業務マニュアル等ドキュメント作成、及び既存プロセスの改善対応 · ユーザーからの問い合わせの一次受けは、保守会社となる外部委託先でメール受付して回答をしますが、委託先で解決しない課題がエスカレーションされます ...
-
Osaka Pepperl+Fuchs SE Full timeJob Description: · The primary objective of this role is to develop and implement a comprehensive business plan for the Process Automation Division in Japan. This includes identifying new business opportunities, building strong relationships with customers and sales teams, and en ...
-
Osaka Microsoft Full timeOverview · 西日本のエンタープライズ製造のお客様を一緒に盛り上げませんか? · 西日本製造営業統括本部にて、西日本のエンタープライズのお客様と将来にわたって戦略的な関係を築き、クラウド活用の推進をリードする技術営業職(Account Technology Strategist:ATS)を募集します。ATSは、業界に特化したお客様のデジタル変革の最前線にいます。候補者は、製造業のビジネスを理解し、業界シナリオに基づき顧客の優先事項を理解し、デジタルジャーニーにおけるリソースを提供するためのプロフェッショナルとして活動します。ATSの技術力に基づ ...
-
Osaka Funded clubAbout AIRS Medical · AIRS Medical Inc., a medical AI startup based in Seoul, Korea, builds innovative products and services to improve patient experience and institutional efficiency. With unparalleled deep learning technology in MR image reconstruction, AIRS has won consecutive ...
-
Osaka Global Blue Full timePurpose of the Role · We are seeking a highly skilled Field Service Specialist to provide frontline user and customer support to our fast-growing business in Japan. · As a Field Service Specialist, you will be responsible for diagnosing and resolving IT-related issues, escalating ...
-
Talent Acquisition
10時間前
Osaka BLR WORLD Full timeJob Title: Talent Acquisition Specialist for Major Events in Japan · We are seeking an experienced freelancer to join our fast-paced team in the major events industry in Japan. As a Talent Acquisition specialist, you will be responsible for combining traditional recruitment metho ...
-
Osaka Uplift People ConsultingAbout Uplift · Uplift is a dynamic agency specializing in global talent search, covering EMEA, LATAM, USA, and APAC. With successful placements in 52 countries, we combine speed and cutting-edge technology to source top executive and mid-senior talent across various functions. Ou ...
-
Osaka Amazon Japan G.K. Full time*Business level of Japanese and English language skill is required for this position · Amazon Japan is looking for a dynamic, organized self-starter to join us as Fulfillment (FC) Finance Manager of the West Region. This position will lead finance and controllership efforts for o ...
-
Osaka Four Seasons Hotels and Resorts Full timeAbout Four Seasons Hotel Osaka · Embodying Osaka's rise as a global city, Four Seasons Hotel Osaka forms the core of a new lifestyle destination at the heart of western Japan's biggest city and the region's hub of commerce and culture. As the city's new icon of luxury and style, ...
-
フィールドエンジニア
6日前
Osaka Carrier Full timeCountry: · JapanLocation: · Osaka BranchRole: フィールドエンジニア · Location: 大阪 · Full/ Part-time: 正社員 · Build a career with confidence · キヤリアエアテクノ(株)では、拠点含めたサービス対応の拡大および、対応スピード等のサービス品質の維持向上、また中形空調領域のシェアアップに貢献するため、リニューアル、他社からの入替等の提案にも注力し、今後も事業成長を図る。その必要人員を充足するため、サービス技術員、施工管理者の募集をいたします。 ...
-
Osaka Rakuten Full timeDescription · To realize the mission mentioned above, the Municipal Sales Group will be responsible for expanding the number of municipalities implementing Rakuten Pay initiatives and increasing transaction volume in the western Japan area, focusing on Kansai, Chugoku, and Kinki ...
-
Hostess
23時間前
Osaka Four Seasons Hotels and Resorts Temps pleinAbout Four Seasons Hotel Osaka · Embodying Osaka's rise as a global city, Four Seasons Hotel Osaka forms the core of a new lifestyle destination at the heart of western Japan's biggest city and the region's hub of commerce and culture. · As the city's new icon of luxury and style ...
-
Osaka Manulife Full timeJob Description · 雇用機会 · お客様は私たちにとって最も重要であり、多くのエンドユーザーは私たちの製品・サービスを信頼して安心した日々をおくることが出来ています。私たちのビジネスの将来のために、重大な問題を解決して価値を提供することが出来る 保険金部 保険金・給付金支払査定者(マネジャー) を求めています。あなたを必要としています。 · 職務内容: · ・保険金・給付金請求案件に関し専門知識と技能に基づき支払査定を行い、決裁する。 · ・保険金・給付金に関する顧客、セールス部門からの照会等に適切に対応し解決する。 · ・顧客視点で ...
-
Operations Associate
18時間前
Osaka Bokksu Full timeYour Future Company · Bokksu is a pioneering direct-to-consumer brand that bridges cultures through its curated snacks and gifts across multiple product lines, including Bokksu Snack Box, Bokksu Market, Japan Crate, Sugoi Mart, and more. We collaborate with small family businesse ...
-
Osaka BLR WORLD Full timeAbout the role · We are currently seeking an experienced Operations Lead for the Kuwait Pavilion at Expo 2025 Osaka. The Operations Lead will be responsible for overseeing all aspects of the Pavilion's daily operations, ensuring a seamless visitor experience and the effective coo ...
-
Osaka Santen Inc 正規雇用Manager, Strategic Execution & Management · 正規雇用 · 会社概要 · Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 · 求人内容 · ■Job responsibility: · -Plan, execute and cascade company's mid-term plan · -Consider ...
-
Osaka Atlas Copco.fit_to_content{width:%;height:auto}The Role: · Job description · ● ビジネス開拓 · - 戦略的な販売計画を作成し、実行する · - 新規顧客訪問及び新製品紹介により、担当地域を開拓する · - セグメント別、アプリケーション別、エリア別に市場の分析を行う · - ディーラーと協力し販売台数を増やす · - 既存のキーアカウント顧客を守り、また新たなキーアカウント顧客を増やす · - 最大限の受注を確保するとともに、コスト管理を行う · ● Business development · ...
-
Osaka Takeda Full timeAbout Takeda · Better Health for People, Brighter Future for the World · We aim to create a diverse and inclusive organization where people can thrive, grow, and realize their own potential while enabling our purpose. · Job Description · We are seeking a highly skilled and motiva ...
-
Osaka Kuehne+Nagel Full timeSea Logistics Customer Care Specialist Key Account · Osaka, Japan | Freight Transport and Customer Service | Full-time · You will join our Customer Care Team to apply your expertise and skills to delivering exceptional customer experiences. · Your Role · To engage with customers, ...
