Manager or Senior Associate, Safety Operations & DM

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 all the case processing and safety data management matters related to pharmacovigilance area activities for products both in development phase and in post-marketing phase.

• Have an expert knowledge of case assessment (causality, seriousness, expectedness, coding, reportability).
• Confirmation on scheduled reports and comply with the regulatory requirements and reporting due date.
• Perform inline approval review and retrospective review of safety case data entry and confirmation on scheduled reports (not only PMDA report but also other reports to regulatory authorities or business partners) with support from supervisor or other function's export as needed.
• Perform Case query process including creating and reviewing follow up letter to Sales reps, communication with Sales reps or other stakeholders with support from supervisor or other function's export as needed.
• Perform ongoing and real time/retrospective QC review under supervisor's oversight.
• Proactive timeline management including due date of individual workflows and submission/transmission under supervisor's oversight as needed.
• Conduct data corrections and case deletions upon the direction from supervisor or GDS Safety Operations & DM as needed.
• Support to develop and maintain required process documents i.e. safety related QMS documents, safety monitoring plan
• Work with other relevant Genmab departments to standardize the safety reporting process language in documents, safety reporting forms according to the local/global reporting requirements.
• Prepare and provide guidance on questions around safety operations based on not only company conventions, but also ICH and regulatory guidance with support from supervisor or other function's experts as needed.
• Oversee and manage SAE Reconciliation activities for post-marketing operations according to the reconciliation plan and generation of SAE reconciliation listings.
• Support to contribute to successful inspection/audit to work with vendors and global/local counterparts with support from supervisor or other function's experts as needed.
• Support to contribute to reliability of GVP related activities for local regulatory requirements with support from supervisor or other function's experts as needed.

• Support to contribute to the effort of selection/implementation of Drug safety solutions for Japan regulatory requirements perspective.
• Create and review documentation to perform tests e.g., test scenarios, for safety system related projects with support from supervisor or other function's experts as needed.
• Perform formal test i.e., User Acceptance Test (UAT) as well as informal test (development environment) on Safety system Related projects with support from supervisor or other function's experts as needed.
• Support to contribute to system development/implementation plan and validation testing according to the URS and UAT scripts.
• Support to generate required periodic listings or ad-hoc tabulations with support from supervisor or other function's experts as needed.
• Support to global Safety Operation & DM team regarding study start-up activities, MedDRA version up activities.
• Review and provide appropriate input to the system configuration or customization requests for safety systems.
• Support to implement or maintain required drug codes (J-Drug Code) or company defined code in Argus safety system.
• Input appropriate education program to the responsible person for introductory training or product specific training.

• Join and support to the appropriate vendor selection activities and implementation for outsourcing activities in Drug Safety Japan.
• Oversee the successful and timely case intake of safety reports and case processing both from the local and global requirements perspective.
• Oversee other activities related safety operations including ICSR submission or distribution to ECs/IRBs/Investigators/Business Partners according to regulatory and company requirements.
• Monitor preferable vendor for Safety operation activities and required quality/compliance and specify/escalate potential significant issues on the vendor activities to supervisor or upper managers in timely manner.
• Oversight reliability of GVP related case processing and quality compliance activities in safety vendor or at Genmab KK. Also report the results to supervisor or upper managers.
• Input appropriate education program to the responsible person for introductory training or product specific training. Review documents (SMP/SOMP, Task Allocation lists, etc.) related to vendor and Genmab activities

• Establish good relationship with global counterparts.
• Closely communicate the product status/regulation updates in timely manner for system configuration perspective.
• Propose potential actions to supervisor/relevant stakeholders for providing the training program on the responsible topics.

• Minimum 3+ years of relevant experience in Safety Operations or Safety data management area
• 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)
• General/Sufficient knowledge of GCP, GVP, GPSP requirements and relevant global GxPs requirements, regulatory compliance and documentation requirements relevant for scope of work.
• General/Sufficient knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
• General/Sufficient knowledge of compliance relevant regulatory obligations, especially pharmacovigilance reporting rules and timelines.
• Experience at least with either clinical or post-marketing case processing, including MedDRA and required drug dictionary coding and narrative writing
• Experience close collaboration with other departments in local and global including license partners.
• English skills (intermediate business communication level or above)
• Willingness to learn & grow new things, i.e. 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

• PV system projects as an IT expert or an advanced user representative (more preferable for ARGUS user experiences)
• Knowledge of ERES (Electrical Records Electrical Signature) / e-documentation requirements
• Conduct case review from scientific perspective for case assessment.
• Re-examination experiences (ICSR case processing part in the inspection, or Response to PMDA queries)
• Clinical (Study) data management experience or EDC for clinical trial data collection experience.
• Clinical operation / monitoring 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).
• Valid permanent residency in Japan
• Native level Japanese in verbal, reading, & writing