PMS Manager or Senior Specialistの求人情報なら転職エージェントJAC


PMS Manager or Senior Specialist

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資



会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>


雇用形態 正社員(期間の定めなし)
勤務地 東京都

<Role Overview>

The primary responsibility is to oversee and manage PMS operations, including Shire-sponsored PMS and observational studies. This includes the planning, designing, and coordinating of PMS, with verification that PMS is implemented accurately and smoothly.

<Key Responsibilities>

・In collaboration with the Head of Drug Safety Japan, relevant Japan, APAC and Global teams, participate and coordinate development of PMS strategy.

・Manage all aspects of PMS and observational studies from planning process to re-examination by the Japanese regulatory authority. Activities include management of budget, reports development, and enrollment, timeline projections, document management and archiving.

・Lead development and maintenance (i.e., including revision and archiving as necessary) of PMS plans and related documents based on PMS strategy agreed by all relevant stakeholders (e.g., pharmacovigilance, medical affairs, clinical development, and commercial strategy).

・Lead and coordinate operational execution of PMS plans including:

-Site activities from site selection through close out, training of medical representatives and other relevant staff

-Data Management, analysis and reporting

-Local contractual management and oversight of CROs and vendors, in alignment with global clinical operations procedures

-Set up PMS team includes external vendors as required, and develop/execute team communications.

・Review, implement and maintain all PMS SOPs to enable PMS to be implemented accurately and smoothly and to align with Shire policies, standards and procedures.

・Develop and implement GPSP training for all relevant internal stakeholders.

・Develop and implement procedures for PMS self-inspection.

・Act as an interface with PMDA in collaboration with PV.

・Support MA and BU in KOL management as necessary.

・Establish and manage communication with APAC and Global team for PMS operations.

<Report to>

Senior Group Manager, PSM




・5+ years’ experience work in PMS

・Excellent working knowledge of GPSP, Japanese regulatory authority requirements, J-GCP/ICH-GCP.

・Excellent verbal and written communication skills required.

・Business level English skills.

・Leadership, management, interpersonal and organizational experience and skills.

・Strong attention to detail.

・Working knowledge of research objectives, protocol design and data collection standards.

・BS or equivalent in scientific or clinical discipline.

・5 years in product development or equivalent experience and at least 3 years clinical operations or equivalent experience;

・International study experiences are preferable.


年収 800万円 - 1200万円