Company OverviewGlobal Pharmaceutical Company
Job DescriptionSpecific 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