Manager, PMS Scientist

ジェンマブは 革新的で独自性のある抗体治療薬の開発に注力し 患者さんの人生をより豊かにすることを目的としています

Position Summary:

The position is responsible for all the PMS related activities and oversight of PMS implementation vendors.

Primary roles & responsibilities include ;

Develop appropriate PMS plan and budget estimation according to the product Risk Management Plan

Implement PMS studies and prepare the final study reports with planned timeline in collaboration with relevant Genmab colleagues and PMS vendor.

Achieve required submission and inspection from regulatory authorities on the PMS area.

Prepare and submit aggregated safety report in collaboration with Safety Scientist and relevant stakeholders including global counterparts.

Develop and maintain Japan Risk Management plan according to the progress of PMS activities and results.

Can act as a designated responsible person (PMS tantosekininshya) in PMS study planning/execution.

Understand all GPSP-related operations and gap with global requirements and procedures.

Responsibilities will include, but are not limited to:

1) PMS planning

In the new product application filing project, develop appropriate PMS planning linked to the Japan Risk Management plan in collaboration with Safety Scientist, Clinical scientist, MA and any relevant stakeholders.

Conduct/contribute to the appropriate PMS vendor selection according to the PMS study plan.

Create resource estimation or request for proposal on PMS vendor selection.

Prepare PMS implementation/operational plan in collaboration with relevant stakeholders (Clinical, MA, Safety and Commercial)

2) PMS Implementation and operations

Oversight vendor’s activities (data management, query confirmation, summary results confirmation)

Check and review the reliability of PMS studies (self-inspection, education and training, etc.)

Conduct appropriate safety communication to supervisor/global counterpart for the risk mitigation.

Other PMS related activities (i.e., cooperation with relevant departments, conduct PMS education program)

3) PMS Reporting and re-examination

Drafting required regulatory reports and documents (i.e. Japan safety periodic report, re-examination application dossier, any response to safety queries form PMDA, MHLW or external stakeholders etc.) on PMS topics.

Conduct periodical aggregated safety review for mainly Japanese domestic cases.

Contribute to create and submit re-examination dossier.

Prepare/action for the GPSP audit, inspection for re-examination or internal self-inspection in collaboration with relevant internal/external stake holders.

Develop and maintain distribution/communication plan for J-PI revisions.

Develop and maintain all required / appropriate safety materials i.e. patient guidance document, guidance for appropriate drug use etc.

Plan and conduct EPPV program if required.

Provide appropriate education program for introductory training or product specific training.

Requirements

Minimum 5 years or more experiences of PMS planning and conducts at GPSP responsible organization (including PV safety management function)

Well knowledge of GPSP requirements and Japan Risk Management plan

Development of product PMS plan and study protocol

Writing study report and (Japanese) periodic safety reports

Oversee the stats of protocol using external PMS CRO or in-house PMS monitor resource

Develop and maintain relevant GPSP and GVP SOPs or process work instructions

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

Optional background

Experiences for responsible person of PMS studies function as delegated responsible person like PMS study (product) lead (Chousa Tantou Sekininnsya : 製造販売後調査担当責任者)

Re-examination experience (Preparation for the submission dossiers, Response to the inspection and PMDA queries)

Data base research (planning or discussion)

Knowledge of ERES (Electrical Records Electrical Signature) / e-documentation requirements

PV risk management and Periodic reporting for safety part

Safety case processing experience

Study data management experience

Study monitor experience

Experiences of clinical operations or clinical datamanagement.

Valid working visa or permanent residency in Japan

Native level Japanese in verbal, reading, & writing

#LI-DNP

私たちは 社員ひとり一人が共通の目的に向かって 高い志を持ち お互いを尊重し 共通の価値観をもとに日々仕事をしています 私たちの価値観の一つである誠実さを胸に 革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます ジェンマブでは がん患者さんの人生をより豊かにすることを目的に 部門や国境を超え 世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています

互いを尊重して協力し合うチームワークは ジェンマブの重要な企業文化であり そのため世界中の社員が インクルーシブ オープン 協力しあう姿勢を大切に日々仕事をしています 地域 教育 文化 国籍 年齢 性別などを超えた多様性を推進し続けていくことが 企業が継続して成長していくために重要であると考えています そのため採用においても 性別 年齢等に関わらず スキルや能力をもとに多様性を重視し進めています

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