Post-Marketing Surveillance Senior Manager (Cho-seki)

​​Essential Functions/Responsibilities 

• ​Act as a PMS Manager, responsible for planning, implementing and communicating PMS activities in accordance with GPSP requirements. 

• ​Support the oversight of safety management processes including, but not limited to, information gathering, case evaluation, safety measure planning and execution, training, record management, safety report submission and periodic report submission. 

• ​Manage and oversee the CRO(s) for Post Marketing Surveillance activities. 

• ​Ensure the planning and implementation of required GVP and GPSP training for JPKK employees and others as appropriate. 

• ​Support safety management (preparation of aggregate reports, self-Inspection) of pharmaceuticals, collaborating with collaborating with the Head of Pharmacovigilance Japan. 

• ​Lead re-examination activities for post-marketing products. 

• ​Act as a back-up for the Head of Pharmacovigilance in Japan. 

• ​Develop and maintain SOPs in compliance with local regulations and that support and are in accordance with corporate SOPs. 

• ​Conduct self - inspections (GPSP) and implement corrective actions if necessary. 

• ​Provide training on GVP and GPSP to safety members. 

• ​Maintain expert knowledge of GVP and GPSP guidelines and local regulatory regulations and maintain awareness of changes to regulatory guidance documents, requirements and PV processes. 

• ​Ensure continuous improvement of Japan safety team activities and procedures collaborating with the Head of Pharmacovigilance Japan. 

• ​Prepare plans, proposals and surveys for implementation of post-marketing surveys, etc. 

• ​Ensure post-marketing surveys, etc. are conducted properly and smoothly in accordance with the standard operating procedures for duties for post-marketing surveys, etc. and the basic protocol on post-marketing surveys, etc. 

• ​Maintain records for drug use-results survey, post-marketing database survey, or post-marketing clinical trial, records 

• ​Support the Head of Pharmacovigilance in Japan in creating reports for the conduct and outcomes of each drug-use results survey, post-marketing database survey, and post-marketing clinical studies. 

• ​Document and record the results of in-house inspections and communicate results to the Head of Safety in Japan and applicable leadership team members 

• ​Agree and action Corrective and Preventative Actions (CAPAs) based on the results of the self-inspection 

• ​Escalate any actual or potential compliance issue to relevant operational bodies in Japan and as well as to appropriate global teams in Jazz/GW. 

• ​Own compliance assessment and remediation plans while influencing execution, communication and training for Safety Management matters 

• ​Provide support for routine activities, projects, development and training relevant to area of expertise where required, ensuring accurate and up-to-date training records. 

• ​In collaboration with appropriate departments, ensure PV obligations are adequately and clearly specified in relevant contractual agreements with business partners and/or external service providers. 

• ​Maintain inspection readiness for PV and GCP audits and inspections and engage in regulatory inspections and internal audits; preparing audit observation responses as necessary. 

• ​Act as a pharmacovigilance point of contact for the PDMA and PV audits and inspections  

• ​Participate in other assigned global PV activities as required 

• ​Participate in periodic oversight meetings held by EU/International PV and QPPV Office team; escalate safety-related issues to Head of EU/International PV & EEA QPPV. 

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​Required Knowledge, Skills, and Abilities  

• ​In-depth knowledge of PMS management for marketing authorisations, GVP and GPSP. 

• ​Excellent analytical skills and ability to interpret PMS results. 

• ​Highly motivated with an interest in PMS, pharmacovigilance and risk management. 

• ​Excellent analytical skills and an ability to think strategically with global perspectives 

• ​At least 5 years of risk minimization measures/safety measures experience in the pharmaceutical industry (ideally at a Japan start up subsidiary of a foreign pharmaceutical company). 

• ​Ability to identify root cause of problem and creatively problem solve to gain resolution 

• ​Ability to prioritize and handle multiple projects simultaneously. 

• ​Strong negotiating skills and an ability to think creatively and to develop creative solutions. 

• ​Fluent in Japanese and sufficient business English level (speaking & writing English) to achieve communication/discussion with global team members 

• ​Excellent oral and written communication skills, liaising with multiple stakeholders both internally and externally including Japanese Health Authorities. 

• ​Excellent leadership skills and an ability to work within a team 

• ​Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint), and PV-related system (preferred) 

• ​Experience/knowledge of re-examination is preferred. 

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​Required/Preferred Education and Licenses 

• ​Degree in Pharmacy, Life sciences or equivalent. 

• ​PMS experience (implementation and utilization of PMS system in Japan) 

• ​Understanding of Risk Management principles and practices 

• ​Understanding of global pharmacovigilance regulations 

• ​Proficient with Safety Reporting systems 

• ​Experience working within multinational pharmaceutical companies 

• ​Experience in PMDA or local government audit/inspection (preferable) 

• ​Experience in Japan Health Authority interactions related to Safety Issues. (preferable) 

• ​Experience being in Cho-seki role (preferable)