ＰＭＳ推進担当者/ スタッフorノンラインマネージャー/医薬開発本部ペイシェントセイフティー＆ファーマコビジランス部ＰＭＳ推進グループ
Basic purpose of the job
- Lead/Manage GPSP operating activities such as data collection, progress tracking, budget tracking, vendor management.
- Conduct post marketing surveillance studies as additional PV plan based on safety specification in compliance with GVP and GPSP regulations
- Contribute to Managerial activities such as fostering group members and budget management.
Accountabilities
1.Ensure timeline and quality of GPSP operational activities including study set-up, making a contract with site, CRF collection, progress tracking, and vendor management
2.Support preparation for Re-examination dossier and inspection readiness
Related performance indicators
Timeline and quality of GPSP activities
Ensure preparation for re-examination inspection readiness
3.Establish and 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
4.Contribute to required budget for each activities and workload / FTE and escalate to PSPV,Monitor and mange actual plan and forecast results
5.Conduct PMS in compliance with GPSP regulations and timely as planned and supprt for preparation of re-examinations dossier and required materials under drug re-examination system appropriately
Related performance indicators
Ensure quality and efficiency of GPSP activities
Ensure quality PMS and re-examination in a timely manner
6.Contribute to manage internal and external resources including partnering with CRO and IT companies to meet required quality, cost, delivery criteria
7.Contribute to define and develop and operate digital and IT infrastructure / application to meet business requirement supporting entire PMS function / operations with secured and sustainable IT environment
8.Contribute to evaluate and streamline PMS monitoring process constantly including outsourcing part of process and /or introducing digital tool in close collaboration with stakeholders (e.g. IT, sales division)
Related performance indicators
Ensure sufficient internal and external resource to keep quality and streamline process
Number of achievement business requirements based on annual activity plan
9.Contribute 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
Related performance indicators
Ratio of talents whose capabilities and/or experiences meet required criteria based on job description and training plan by each position layer
10.Ensure appropriate selection, contract and purchasing CRO/vendor and manage the progress and quality of the outsourced CRO / vendors, provide appropriate guidance, and consider changing the CRO if necessary.
11.Ensure PMS related training including PMS monitoring related training are provided to both internal and external (as needed) PMS monitor
12.Define appropriate digital / real channel (e.g. mail, call center, EDC system, online engagement) to provide HCPs with efficient support on participating survey
Related performance indicators
Ensure to keep quality and streamline process
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 extensive regulatory, scientific, epidemiological and medical knowledge . This needs to take into account needs and requirements of other functions, departments and units.
Interfaces
Primary care business unit, Specialty care business unit, global PSPV, PMS Strategy planning group, BDS, Primary care Medicine, Specialty care Medicine, IT, QM
Job Expertise
5+years’ experience in pharamacovigilance and PMS
Experience of PMS monitoring is preferable.
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 and experience of PMS monitor
・Experience in CRO management
・Knowledge and experience of PJ management
・Experience of customer engagement (preferable)
・Excellent command of English language (toeic score more than 700)
Skill and Competencies
・Proactive and assertive attitude to establish team and networking
・Problem solving skill
・Conceptual and strategic thinking
・Learning agility
・Project management and decision-making skills
Required English speaking CEFR level : B1
Recruiter : Suzuki