Make your mark for patients

患者さんのためにあなたの力を発揮してください

※フルリモート不可/Hybrid work model

※Please check if the candidate has applied for a job at UCB in the past year.　一年以内のご応募歴を必ずご確認ください。

※Please make English and Japanese resume combined in one document to submit　英語と日本語の書類を一つに纏めてご提出ください。

※If you have any questions, please contact recruiting team 質問がございましたら採用チームまでお問い合わせください

JOB SUMMARY

Primary Purpose / Regulatory Responsibilities:
    As a team member to ensure that Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate Japan.
    Manage and implement Post-marketing survey (PMS) in compliance with GPSP, GVP, and related regulations and procedures to facilitate pharmacovigilance systems, and appropriate use for marketed drugs after approval in Japan.

 MAJOR RESPONSIBILITIES 
Pharmacovigilance System
    Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements;
    Work in collaboration with corporate Patient Safety teams to ensure that local obligations are managed and compliance to local authorities is maintained;
    Provide input into global/local processes to secure compliance;
    Maintain quality management system related to the pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs;
    Maintain oversight of local deliverables delegated to service providers; 

Post-marketing surveillance System
    Collection, analysis, and dissemination of information related to the quality, efficacy, and safety of products under development and develop post-marketing surveillance plan;
    Settle appropriate approaches to research questions and decide study protocol;
    Evaluate and analyze study results for appropriate use;
    Form an operational control framework for all the documents related to PMS activities to cope with PMDA inspection;
    Submit and apply re-examination applications/J-PSUR for UCB products as the MAH;

Health Authority inspections and Audit readiness
    Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance;
    Participate pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective Actions Preventive Actions (CAPAs);

Stakeholder Management
    Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance; 
    Engage external stakeholders e.g. scientific community, patient advocacy groups, regulators and pharma industry for insights that leads to solutions for patients.

EDUCATION & QUALIFICATION 

Education Level:

1    Bachelor's Degree
1    Other : HCP based education (e.g. physician, pharmacist, nurse) or any relevant graduation/experience in medical-scientific area e.g. PhD/Master in biological sciences or related degree)

COMPETENCIES 
Competencies
Refer to PS competencies on UCB Plaza- PS Competencies for the profile of ‘International Pharmacovigilance’

Specific Skills (Include specific skills and knowledge necessary to meet the objectives of the position)
    Expert in pharmacovigilance, with an in-depth expert knowledge of associated regulatory requirements
    Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives to aim for 100 % compliance
    Have interpersonal skills
    Team working and networking promoter
    Leadership, qualities of authenticity, resilience and adaptability
    Excellent oral and written communication skills as the individual in this position will be interacting with multiple levels and diverse functions (e.g. commercial, quality, regulatory, legal, medical) within and outside UCB e.g. regulators, patients, HCP’s, Pharma industry associations
    Excellent verbal and written communication in English
    Demonstrated ability to understand, analyze, and summarize scientific and medical information
    Professional demeanor, team orientated, self-motivated, and ability to influence stakeholders both externally and internally
    Problem solving: 
a.    Solid foundation for making quick, sound decisions, based on limited information

患者さんのために価値を創造し、ご自身の力を発揮する準備ができているとお感じでしたら、ぜひ私たちにご連絡ください。

会社概要

UCBは、神経および免疫領域に注力するグローバルなバイオ医薬品企業です。世界中で約8,500人の社員が、患者さんからインスピレーションを受け、科学の力で前進しています。

UCBで働く魅力

UCBでは、単に業務をこなすのではなく、価値を創造することを大切にしています。私たちは挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。
誰もが尊重され、受け入れられ、最善を尽くせる平等な機会がある、思いやりと支援に満ちた文化が根付いています。
私たちは常に「その先」を目指し、患者さん、社員、そして地球に対して人間らしさを大切にした価値を提供しています。
UCBで働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限に引き出すことができます。

UCBでは機会均等を重視しています。すべての採用決定は、法律で保護されているいかなる属性にも関係なく行われます。

選考プロセスにおいて、ご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は、以下のメールアドレスまでご連絡ください：

EMEA-Reasonable_Accommodation@ucb.com

※なお、この問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんので、ご注意ください。