Job Description

Company Overview
Global Pharmaceutical Company

Job Description
Specific Responsibilities:
• Acts as Post-Marketing Study Lead with support by CPM.
• Serves as a chair person of cross-functional study management team to manage entire PMS activities in Japan in close collaboration with ClinOps, PVE (Pharmacovigilance and Epidemiology), Clinical Research, Regulatory Affairs and Biometrics in GSJ and HQ.
• Contributes to develop PMS protocol (including PMS plan in the Japan Risk Management Plan: J-RMP) and CRFs in collaboration with functional team in Japan/HQ.
• Supports CPM and prepares for negotiating with PMDA about the protocol and CRF design based on the scientific approach and PMS result by preparing response to PMDA queries.
• Proceeds CRO selection process including preparation of RFP (Request for Proposal), CRO selection and Work Order execution according to SOP in collaboration with appropriate function in Japan/HQ with minimum support by CPM.
• Oversees budget and forecast process for payment to CRO, clinical sites and translation vendors.
• Communicates with PVE personnel and drafts safety reporting strategy of PMS studies in collaboration with functional team in Japan/HQ.
• Ensures to prepare PMS part of J-PSR (Japan Periodic Safety Report) and Re-examination report in English and Japanese in collaboration with appropriate function in Japan/HQ with minimum support by CPM.
• Oversees CROs and resolve fewer complex issues, or complex issues with support, to ensure study quality, complying with work order, SOPs and regulatory requirements within agreed timeline.
• Prepares training plan and materials and gives training to GSJ therapeutic specialist (aka. Medical Representatives) and CRO personnel with support, if necessary.
• Prepares and maintain GPSP SOPs, prepares training plans and gives necessary trainings to those in Japan/HQ who involve PMS activities with support, if necessary.
• Deals with the Audit/Inspection by Regulatory authority or Regulatory compliance with support by CPM.
• Prepares a TMF plan and manages to archive documents based on the TMF plan with support, if necessary.
• Support early phase (Ph.2 or 3) clinical trial, if needed.

 Must have demonstrated organizational /project management skills to manage simple/small project or multiple /complex projects simultaneously with support by CPM.
 Hands-on involvement is a must (effective use of external resources).

 Strong communication and influence skills and ability, or potential to create a clear sense of direction is necessary
 Experience in PMS at least 5 years.
 Registered Pharmacist is preferred
 Experiences in PMS planning and execution.
 Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GPSP governing the conduct of PMS is required
 Good skills of communication in Japanese and English (>750 TOEIC)
 Experiences in selection and oversight of CROs and vendors.
 Proven good communication skills and evidence of able to work in cross functional teams
 Travel is required