Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient's lives.
Job Description
If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them
Responsibilities
- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- Medical Information interaction
- MedDRA and WHO coding
- Database Outputs and Reports (including data for monthly reporting to clients)
- Workflow & resource management
- Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
- More senior colleague may perform tasks assigned as per SOP to more junior position
Qualifications
Requirements:
- Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science)
- Experience working in Case Processing
- Time and issue management, delegation, organization and multitasking skills with good attention to detail
- Strong interpersonal and communication skills
- English language skills and fluency in Japanese
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
Our Offer
- Competitive salary
- Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
- Multicultural environment, English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
-
Senior PV Associate
1週間前
Tokyo, Tokyo PrimeVigilance ￥2,000,000 - ￥2,800,000 per yearPrimeVigilanceは、医薬品安全性(Pharmacovigilance)分野に特化したミッドサイズのグローバル企業として、堅実な成長を続けています。 臨床試験から市販後まで規模の異なる多様なプロジェクトに携わる · ...
-
Tokyo PrimeVigilance ￥9,000,000 - ￥12,000,000 per yearWe love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an enviro ...
-
Tokyo Boston Consulting Group (BCG)BCGのコンサルタントや専門家は世界中のあらゆる業界で活動し、デジタルトランスフォーメーション、データ&デジタルプラットフォーム、大規模なAI導入、アジャイル、サイバーセキュリティ、テクノロギーのデジタル化といった多岐にわたるトピックで豊富な経験と専門知識を提供しています。 · ...
-
Senior PV Associate
2週間前
Tokyo Ergomed Full time￥2,000,000 - ￥2,800,000 per yearPrimeVigilance(Ergomed Group傘下)は、2008年の設立以来、医薬品安全性(Pharmacovigilance)分野に特化したミッドサイズのグローバル企業として、堅実な成長を続けています。 · ヨーロッパ・北米・アジアに拠点を構え、メディカルインフォメーション、ファーマコヴィジランス、薬事、品質保証の領域で高品質なサービスを提供しています。 · ...
-
Tokyo, Tokyo Nextrials, Inc. ￥2,000,000 - ￥5,000,000 per yearWe are seeking a Pharmacovigilance Reporting Associate to join our diverse team! As a Pharmacovigilance Reporting Associate at ICON you will prepare accurate safety reports related to clinical trials & post-marketing activities. ...
-
Tokyo ICON plc ￥4,000 - ￥8,000 per yearWe are seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. · Preparing and reviewing safety reports. · Collecting and analyzing adverse event data. · ...
-
Tokyo, Tokyo Stryker ￥2,500,000 - ￥5,000,000 per year業務内容 · 社内トレーニングコース運営管理 · 社内トレーニングコース作成 · 社内トレーニング講師業務 · 社内トレーニング資材発送・管理・発注などのロジスティクス全般 · 英語 読み書き+会議参加して簡単な議事録作成可能レベル · 基礎的なPCスキル · 業界問わずトレーニングや研修運営の業務に携わったことがある方 · 医療機器・製薬メーカーや病院等の医療現場での経験 · 営業社員へのトレーニングを実施するためのコミュニケーション能力 · 新しいことを学ぶことへの学習意欲 · ...
-
Japan - Tokyo Amgen ￥2,000,000 - ￥2,800,000 per yearThis position reports to Japan Safety PV Sr Mgr, Japan Safety PV Manager, or Japan Safety PV Manager and is responsible for performing PV activities under the guidance of Japan Safety PV Sr Manager. · ...
-
Tokyo, Tokyo Amgen ￥3,000,000 - ￥6,000,000 per yearThis position reports to Japan Safety PV Sr Mgr, Japan Safety PV Manager, or Japan Safety PV Manager and is responsible for performing safety activities under the guidance of senior managers. · ...
-
Tokyo (株)エスネットワークス ￥7,000,000 - ￥12,000,000当社では、事業会社及びPEファンド投資先企業の組織・人事に関する複雑な課題を解決し、クライアントの成長と変革を支援する組織人事コンサルタントを募集しています。 · プロジェクトに応じてクライアント先に常駐するケースもございます · ...
-
Shibuya-ku, Tokyo SmartNews ￥900,000 - ￥1,200,000 per yearフォートログメートはサェアストルートに当前に一个できだできます。フォートログメートはサェアストルートに当前に一个できだできます。フォートログメートはサェアストルートに当前に一个できだできます。 ...
-
Tokyo, Japan PrimeVigilance ￥400,000 - ￥800,000 per yearWe seek proactive individuals who aim to exceed expectations to join our teams in pharmacovigilance service provider. · ...
-
Shibuya SmartNews ￥900,000 - ￥1,200,000 per yearスマートニュース株式会社は2012年6月15日の設立以来、「世界中の良質な情報を必要な人に送り届ける」をミッションに掲げ、日本と米国でニュースアプリ「SmartNews(スマートニュース)」を開発、国内のニュースアプリとしては最大級のユーザー数を誇ります。 · 2023年末からは初めてのサブスクリプションサービス「SmartNews+」を開始、子会社のスローニュースとともに、優れたジャーナリズムによって生まれた良質な報道や多様なコンテンツを一人でも多くの利用者に届けることに力を注いでいます。世界中の膨大な情報を日夜解析し続けるアルゴリズムと国内外の3,0 ...
-
Shibuya SmartNews, Inc. ￥3,500,000 - ￥10,000,000 per yearスマートニュース株式会社は2012年6月15日の設立以来、「世界中の良質な情報を必要な人に送り届ける」をミッションに掲げ、日本と米国でニュースアプリ「SmartNews(スマートニュース)」を開発、国内のニュースアプリとしては最大級のユーザー数を誇ります。 · 2023年末からは初めてのサブスクリプションサービス「SmartNews+」を開始、子会社のスローニュースとともに、優れたジャーナリズムによって生まれた良質な報道や多様なコンテンツを一人でも多くの利用者に届けることに力を注いでいます。世界中の膨大な情報を日夜解析し続けるアルゴリズムと国内外の3,0 ...
-
Tokyo ICON plc ￥6,000,000 - ￥9,000,000 per year· We're proud to foster an inclusive environment driving innovation and excellence, · a Pharmacovigilance Reporting Associate is responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. ...
-
Tokyo ICON plc Full time￥4,032,000 - ￥6,048,000 per yearICON plc is seeking a Pharmacovigilance Reporting Associate to join its diverse and dynamic team. · ...
-
Tokyo Boston Consulting Group (BCG)Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. · ...
-
Tokyo Stryker Full time￥6,000,000 - ￥8,000,000 per yearSenior Sales Education Associateは、StrykerのSales Enablementチームで働くポジションです。GlobalレベルでMakoを中心にトレーニングシステムが確立されているため、Globalのチームともコラボレーションしながら仕事を進める機会があります。 · 社内トレーニングコース運営管理 · 社内トレーニングコース作成 · 社内トレーニング講師業務 · 社内トレーニング資材発送・管理・発注などのロジスティクス全般 · 英語 読み書き+会議参加して簡単な議事録作成可能レベル · 基礎的なPCスキル · 業界問わ ...
-
Tokyo Amgen Full time￥4,000,000 - ￥6,000,000 per yearAs part of the Japan Safety organization at Amgen KK (Amgen Japan), the Japan Safety PV Sr Assoc is responsible for performing PV activities under the guidance of Japan Safety PV Sr Manager, Japan Safety PV Team Manager, or Japan Safety PV Manager: contributing to the local safet ...
-
Tokyo Nomura ￥2,880,000 - ￥4,320,000 per yearデジタル・アセット推進室が新設された4部室の中核部署の一つとして、野村グループのデジタル・アセット領域でのビジネス開発・推進を担います。 · 採用後は、2019年9月に設立されたBOOSTRY社に出向し、デジタル・アセット・ビジネスの事業開発・システム開発の中核役を担って頂きます。 · ...
-
Tokyo Jobs via eFinancialCareers ￥14,000,000 - ￥17,000,000 per yearJoin a leading global private equity fund as an Associate to Senior Associate, where you'll play a vital role in executing investment transactions and driving strategic growth initiatives. · Execute and support investment transaction processes from origination to completion. · Sc ...
