Job Overview
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
Essential Functions
- To Prioritize and complete the assigned trainings on time.
- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events(AE)/endpoint information
- determining initial/update status of incoming events
- database entry
- coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
- Creating, maintaining and tracking cases as applicable to the project plan.
- Identify quality problems, if any, and bring them to the attention of a senior team member.
- To demonstrate problem solving capabilities.
- Liaise with different functional team members, e.g. project management, clinical, data management
- health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
- May liaise with client in relation to details on day to day case processing activities.
- To mentor new teams members, if assigned by the Manager.
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
- Perform other duties as assigned.
- Lead/ Support department Initiatives
- 100% compliance towards all people practices and processes
- In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.
Qualifications
- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
- Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req
- or equivalent combination of education, training and experience. Pref
- Good knowledge of medical terminology. Intermediate
- Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate
- Excellent attention to detail and accuracy. Intermediate
- maintain high quality standards. Intermediate
- Good working knowledge of Microsoft Office and web-based applications. Intermediate
- Strong organizational skills and time management skills. Intermediate
- Strong verbal/written communication skills. Intermediate
- Self-motivated and flexible. Intermediate
- Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate
- Ability to delegate to less experienced team members. Intermediate
- Ability to be flexible and receptive to changing process demands. Intermediate
- Willingness and aptitude to learn new skills across Safety service lines. Intermediate
- Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate
- Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate
- Ensure quality of deliverables according to the agreed terms. Intermediate
- Demonstration of IQVIA core values while doing daily tasks Advanced
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate
- Regular sitting for extended periods of time. Intermediate
- May require occasional travel. Intermediate
- Flexibility to operate in shifts. Intermediate
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
-
Tokyo IQVIA ￥2,500,000 - ￥4,500,000 per yearReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guideline ...
-
Tokyo IQVIA Full time￥2,500,000 - ￥5,000,000 per yearReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guideline ...
-
Tokyo IQVIA ￥2,500,000 - ￥5,000,000 per yearReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guideline ...
-
Tokyo, Japan IQVIA ￥2,500,000 - ￥4,500,000 per yearReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guideline ...
-
Tokyo Philips ￥55,000,000 - ￥70,000,000 per year医療機器の市場出荷に必要な検査・試験・包装表示作業のマネジメント · 市場への出荷判定 · QMS文書作成改訂/管理 · 製造所・ベンダーのQCD管理 · 製造所に関する品質・プロセス改善のリード(3PLやGlobalとのコミュニケーション含む) · 関連部署(品質管理、薬事、マーケティング、SCM等)との調整による製品品質・納期の維持 · 内部・外部監査対応 · 経験(MUST):製造・品質管理・品質保証等の生産関連業務経験(医療機器に限らず)3年以上 · 経験(WANT):医療機器製造業責任技術者経験、チームマネジメント経験、QMS監査経験、サプライ ...
-
Tokyo Skillhouse Staffing Solutions K.K. ￥6,000,000 - ￥10,000,000 per yearOnline Travel Platform -specializing in booking local tours and experiences worldwide, is seeking a · Site Reliability Engineer · Design, build, and operate the application infrastructure for the main platform (DevOps-focused) · Oversee both B2C and B2B systems, taking ownership ...
-
Stores Analyst
2週間前
Tokyo, Japan Ocado Group ￥2,500,000 - ￥4,000,000 per yearカスタマーフルフィルメントセンター(物流倉庫)において、効率的、効果的、安全で整理整頓されたストアルームを管理する。部品や消耗品の在庫管理や発注・請求書の処理など、オペレーションチームが実施する必要なメンテナンス活動に対して、予備部品を提供する。 · CMMSを用いて、メンテナンス等に必要な部品・消耗品の在庫レベルを管理し、必要な発注を実施する。 · 適切な在庫量を維持できるように、必要なアクションをとる。 · オペレーションチームが正しい部品を用いることができるようにサポートする。 · 発注業務に必要なタスクを実施する。 · 配送されてきた部品の検査、 ...
-
Tokyo digit Inc. ￥4,000,000 - ￥8,000,000 per yeardigitは、デジタル&ソーシャルを起点として、ブランドの非連続な成長を支えるデジタルマーケティングエージェンシーです。ECグロースマネージャーは、digitのクライアントのECビジネス成長を支えるパートナーとして、プラットフォーム戦略の立案から広告運用、ストア最適化まで一気通貫でリードします。 · 大手クライアントのEC事業のグロース戦略の立案 · Amazon、Rakuten等の主要ECプラットフォームにおけるストア最適化提案及び実行 · Amazon DSPなどECプラットフォームを活用した広告施策の立案と実行 · ECストア及び広告のデータ分析・ ...
-
Tokyo TEKsystems Remote job￥900,000 - ￥1,200,000 per yearBilingual Application Support Specialist A global lifestyle brand is seeking a Bilingual Application Support Specialist to join its Japan-based IT team, primarily supporting e-commerce operations in the Korean market. · Provide operational and technical support for backend e-comm ...
-
Tokyo Third Bridge Group Limited ￥900,000 - ￥1,200,000 per yearWe are looking for a motivated analyst to join our team in Tokyo. On a daily basis you will be engaging industry thought leaders to drive insights on Japanese industries and businesses directly to our clients. · Conduct research on industries, public and private businesses in Jap ...
-
Greater Tokyo Area POP MART ￥300,000 - ￥600,000 per yearWe are looking for a detail-oriented and hands-on Visual Merchandising Specialist to support the daily execution of in-store visual merchandising operations. This role is essential in delivering consistent, high-quality brand presentation across all stores in Japan. · Execute day ...
-
Tokyo Stella McCartney ￥4,500,000 - ￥7,500,000 per yearWe are seeking a Payroll Specialist to manage a variety of personnel-related administrative duties, including processing payroll for 100+ employees in Japan in coordination with our payroll vendor, and maintaining personnel records in Workday. · Supporting the Head of People in t ...
-
Tokyo Miro ￥2,000,000 - ￥2,500,000 per yearLead the go-to-market execution for one of Miro's newest offerings, generating demand, delivering strategic demos, and closing the first wave of customer deals. · Execute targeted sales motion to land early customer deals, pressure testing positioning, pricing, and solution desig ...
-
Tokyo Red Bull ￥3,000,000 - ￥6,000,000 per yearThe Trade Marketing Specialist is responsible for detail planning of Consumer Activation Plans (CAP), In-store executions and communications to maximize sales by driving instore visibilities and delivering Look Like #1. · DEVELOP CONSUMER ACTIVATION PLANS BY FULLY UTILIZING RED B ...
-
Tokyo, Tokyo G Talent ￥3,600,000 - ￥5,400,000 per yearSoftware Development Engineer responsible for requirement definition, basic design, detailed design, implementation, testing, release, maintenance and operation in software development. · ...
-
品質保証エンジニア
2ヶ月前
Tokyo Mico ￥4,500,000 - ￥7,500,000 per yearThe role primarily involves leading the promotion, design, and implementation of automated testing aimed at improving the quality of our multi-product lineup, particularly centered on our flagship product, Mico Engage AI. · Planning and strategizing test automation across multipl ...
-
Project Manager
2ヶ月前
Tokyo, Tokyo CI&T ￥6,000,000 - ￥12,000,000 per yearWe are tech transformation specialists, uniting human expertise with AI to create scalable tech solutions. Located in Tokyo, the Project Manager is a full-time position that participates in all phases of the project lifecycle and consistently delivers business value to our client ...
-
Tokyo TaskUs ￥4,000,000 - ￥6,000,000 per yearThe Talent Acquisition Specialist is responsible for delivering all facets of the recruiting process throughout the organization. They are responsible for hiring the best possible talent through traditional sourcing strategies and resources as well as developing new, creative rec ...
-
Legal Specialist
2ヶ月前
Tokyo Servier ￥3,500,000 - ￥6,000,000 per yearManagement of local Legal matters. Reporting directly to the Head of Legal and Compliance of Nihon Servier Co., Ltd. · Consultation on various legal issues and solution proposal (including legal consultation of the business schemes, seal management) · Contract review (Japanese an ...
-
Tokyo, Japan Deckers ￥3,500,000 - ￥6,500,000 per yearAs Integrated Marketing Manager at HOKA in Tokyo, Japan you will be responsible for seasonal marketing planning and execution. · ...
-
Tokyo, Tokyo BoF Careers ￥4,000,000 - ￥8,000,000 per yearIntegrated Marketing Manager responsible for seasonal marketing planning and execution, people management, communication, and analytics. The role requires a deep understanding of Japan consumers and the ability to work collaboratively with global and regional marketing teams. · T ...
