NHS Human Services, Inc.

Basic purpose of the job*

• Lead/Manage GPSP operating activities such as data collection, progress tracking, budget tracking, vendor management with support.

• Conduct post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations

Accountabilities *

1.Plan PMS in compliance with GPSP regulations and timely as planned and prepare re-examinations dossier and required materials under drug re-examination system appropriately

2.Manage preparation for Re-examination dossier and inspection readiness with support.

3.Manage the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPV

Related performance indicators

Ensure quality PMS and re examination in a timely manner

Ensure preparation for re examination inspection readiness

Ensure local periodic report preparation in time and provide quality documents

4.Contribute to ensure internal and external resources including partnering with CRO and IT companies to meet required quality, cost, delivery criteria

Related performance indicators

Ensure quality and efficiency of GPSP activities

5.Support local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate

Related performance indicators

Ensure inspection readiness

6.Support strategy development and implementation from short and mid-long perspectives so that every NBI member can comply with regulation and continuously contribute to close medical safety gap for patient

Related performance indicators

Obtain positive feedback by internal and external ( HCPs who are counterpart of PMS survey)evaluation on PMS strategy & planning

7.Support improvement of business process to ensure efficiency, transparency, compliance, and insightfulness through cross-functional collaboration and data utilization

Related performance indicators

Obtain positive feedback by external evaluation on customer experience (e.g. medical / scientific value, user friendly/user experience , motivated) from HCPs who are counterpart of PMS survey

8.Support to ensures a positive Customer experience by engaging with appropriate functions that support Customer Engagement activities (e.g. S&O, MA) by continuously keeping communication and establishing an interface or platform that allows improvement of CE and its KPIs

Related performance indicators

Obtain positive feedback by external evaluation on customer experience (e.g. medical / scientific value, user friendly/user experience , motivated) from HCPs who are counterpart of PMS survey

Regulatory and / or Organisational Requirements*

• Follows government regulations and company standard operating procedures relevant to quality management system (QMS), Good Post-Marketing Study Practice(GPSP), good vigilance practice(GVP).

• Be compliant and acts within ethics at all times.

Job Complexity*

The position requires solid regulatory, scientific, epidemiologicaland medical knowledge .

This needs to take into account needs and requirements of other functions, departments and units.

Interfaces*

Global patient safety& pharmacovigilance, CO&D Japan, Primary Care Medicine, Specialty Care medicine, LRA, QM, Primary care business unit, Specialty care business unit

Job Expertise*

3+years’ experience in pharamacovigilance and PMS

Job Impact*

Conduct and Establish internal/external collaborations by sharing best practices

Minimum Education/Degree Requirements*

Bachelors Degree

Required Capabilities (Skills, Experience, Competencies)

Knowledge and experience

・Knowledge about local GPSP/GVP regulation and local and international NIS study

・Knowledge and experience of PMS administrative task

・Good command of English language (toeic score more than 600) Skill and Competencies

・Proactive and assertive attitude to establish team and networking

・Problem solving skill

・Conceptual and strategic thinking

Recruiter: Miki Tomatsu

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.