Senior Manager/Manager, Safety compliance & Alliance

ジェンマブは革新的な抗体医薬の開発に注力し、患者さんの生活を改善することに力を尽くしています。

私たちは、extra[not]ordinary® な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。

ジェンマブは思いやりがあり、率直で、患者さんに貢献したいという強い思いを持った人たちがともに働き、科学に基づく変化をもたらします。大胆さと高潔性を持って行動し、新しい未来をつくることを目指すこと が、この使命を果たすために不可欠だと信じています。

私たちは大きな志を掲げ、楽しく、そして思いやりの心を忘れずに、日々意義のある仕事に取り組んでいます。私たちは、個々のユニークな貢献を受け入れ、それらを原動力として、患者、ケアパートナー、ご家族、そして社員のニーズを満たす革新的なソリューションを生み出し、育み、維持するグローバルな企業文化の構築に努めています。

私たちの想いに共鳴し、自分らしく活躍できそうだと感じたら、ぜひ一緒に働きましょう。

Position Summary:

The position is responsible for leading and acting regarding the following PV related topics in collaboration with global Drug Safety & PV (GDSPV) and relevant Genmab KK colleagues.

Primary roles & responsibilities include;

Develop and maintain PV quality process/metrics and department dossiers. Develop and maintain PV filing process and lunch readiness. Support and contribute to PV Processes, training and new staff on-boarding process. Establish and maintain training or self-inspection process per local GVP/GPSP requirements. And lead the implementation.

• Consult or collaborate with other members in the Drug Safety & PV Japan as a superuser of Document Management System (GenDocs) and as a workflow coordinator, local documentation administrator, and support).
• Manage and maintain all local pharmacovigilance policies, procedures, and work instructions, and support to develop and implement those QMS documents for the investigational and marketed product safety surveillance in collaboration with GDS contact and relevant Drug Safety Japan members.
• Manage and oversee the Quality Event process such as change management, CAPA, and deviation, resulting from regulatory compliance monitoring, and work closely with the GDS & PV compliance and Global QA to address and document responses.
• Provide support to Drug Safety & PV Japan with regulatory compliance oversight relevant in compliance with current regional regulations, internal and external guidance documents, and Standard Operating Procedures.
• Oversee and manage Pharmacovigilance-related product launch responsibilities for both joint commercial launches and internal launches.

• Perform the set-up activities including liaising with internal/external stakeholders, informing QPPV office, GDS&PV Physicians and Scientists as appropriate of new activities, confirming safety language in contracts, and performing safety training.
• Support appropriate vendor selection/contracts and consult the agreement and CDAs in collaboration with Contract Management, Finance or Legal.
• Support and join Safety vendor, meetings and overall alignment.
• Manage the negotiation process, implementation and regulatory compliance oversight of safety data with contractual partner counterparts.

• Establish/maintain training Matrix, Job to Learner Role Map for the Drug Safety & PV Japan, and user access of GenDocs training in collaboration with R&D Training Management and the GDS & PV.
• Support the safety training for all PV relevant internal and external team members and distribute QMS documents to local PV vendors.
• Evaluate new and revised information on global policies, procedures, and work instructions and their impact on the GenDocs training plan for the Drug Safety & PV Japan.
• Arrange overall pre-filled Training & Assessment Plans to PV hiring managers for the new hire at Drug Safety Japan

• Support Anseki/Choseki to ensure compliance with regulatory authority guidelines and regulations as well as keeping abreast of Pharmacovigilance methods and trends in published literature and global regulations.
• Support Anseki/Choseki to create annual/additional training plan and self-inspection under Japan GVP/GPSP requirements.
• Conduct and coordinate the required Japan GVP/GPSP training according to the plan.
• Conduct and coordinate self-inspection according to the plan.
• Conduct appropriate documentation and filing of training records/self-inspection report.
• Establish and maintain a records management process for electronic GxP records in accordance with relevant guidelines/guidance.

• Obtain the latest information from local stakeholders regarding the source of safety data that Genmab KK run at time of DLP for updating PSMF Appendix C.
• Update and save the information and change log of the draft of PSMF Appendix C by the specified due date in the system.

• Minimum 7+ years of relevant experience in Pharmacovigilance/Clinical Research
• Experience executing process/projects in own area (e.g. regulations & reporting requirements, preparation of post-marketing and clinical safety assessment, safety case processing, PV data systems and PV report generation)
• Experience guiding team members around complex issues.
• Proven performance in earlier role/comparable role.
• Proficient or advanced knowledge of GCP, GVP, GPSP requirements and relevant global GxPs requirements, regulatory compliance and documentation requirements relevant for scope of work in addition to Japanese requirements.
• Proficient skills in evaluating, identifying, and implementing safety processing/reporting/evaluation systems to drive compliance around PhV activities.
• Closely collaborate with other departments in local and global including license partners.
• Leading and coordinating experience of communication with regulatory authorities PMDA/MHLW in relation to GVP and GPSP topic including regulatory inspection/Partner audit/self-inspection etc.
• Developing skills in managing people, establishing goals and objectives, giving feedback and having frequent career conversations while shaping their career growth within and outside the department.
• English skills (minimum: base business communication level without translator)
• Willingness to learn & grow new things, ie fast learner
• Strong interpersonal & communication skills
• Bring out-of-box thinking and will to make it happen
• Proactive, constructive attitude & behavior, self-starter
• Executions with strategies, attention to details

• Conduct case review from scientific perspective for case assessment and good documentation.
• Safety Management experience (J-PI revision based on critical safety issues and safety alerting to internal/external stakeholders)
• Re-examination experiences (ICSR case processing or any other safety activities in the inspection, or Response to PMDA queries)
• Clinical (Study) data management experience
• Clinical operation / monitoring experience, GCP inspection experience
• Experiences of activities related to Pharmaceutical Manufacturing/Marketing Company License (Gyokyoka)：The Initial License Registration (製造販売業許可申請), The renewal of License (製造販売業許可更新).