Group Manager, PMS Strategy Planning Group, Patient Safety & Pharmacovigilance Dept, Medicine Div.

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.Lead/Manage preparation for Re-examination dossier and inspection readiness

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

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

Ensure inspection readiness

5.Lead 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

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

6.Lead to improve business process to ensure efficiency, transparency, compliance, and insightfulness through cross-functional collaboration and data utilization

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

7.Lead to empower individuals and attractive for those who are not only safety and regulatory expert but also can proactively lead him/herself and team and key stakeholders

Ratio of talents whose capabilities and/or experiences meet required criteria based on job description and training plan by each position layer

8.Lead to plan and execute PMS strategy from both short and mid-long perspectives so that PMS strategy continuously contribute to close medical needs for patient based on domestic and overseas academic trends and clinical needs, which provides valuable information from medical, scientific, and social perspectives

9.Plan to ensure providing  scientific evidence valuable for both HCPs and Patient through company / global-wide collaboration (e.g. collaboration with strategy and operations) with customer centric approach.

10.Lead strategic design of PMS aligned with MA and MKT teams in regard to usage of RWE collected as part of PMS. She/He co-leads with Epidemiology team the strategic design of database and analysis, for future communication.

11.Ensures that insights from PMS activities are collected, analyzed and appropriately shared within the organization

12.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

Obtain positive feedback by internal and external evaluation on stakeholder experience (e.g. medical / scientific value, clinical needs,patient's needs)

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

13.Ensure to build relationship with internal and external stakeholder, to be known as a leader of industry,contribute to achieve ideal state of PMS and address industry-wide agenda through collaboration with industry peers (e.g. HCPs Pharma industry, MHLW, patient advocacy group)

Obtain positive feedback by stakeholders

14.Ensure to perform managerial activities such as planning group budget and resource planning, sending and receiving escalation of issues to/from stakeholders, supervising managers, staffs, assistants and trainees of the group, executing HR related responsibilities and monitoring group goal and capacity.

Obtain positie feedback by stakeholders (i.e. supervisor, group members and peers)

Ensure proper budget allocation, resource planning and the right strategic prioritization. Lead and drive escalation discussion for group's projects.

Ensure safe and healthy work environment and provide group members with supports and advices to achieve the goals of the assigned PMS

MAGs, Talent Management, vacation planning, performance evaluation reports.

Status overviews including capacity needs.