This role will be charged with the safety monitoring activities for PMS studies in Japan, in collaboration with the PMS team and the relevant program teams for each therapeutic area. This individual has the required medical and scientific expertise and is able to integrate the input from various disciplines to help create, maintain, and support the execution of the PMS studies in Japan that will support the company s business objectives.
Review and provide input into the study protocol as it is developed.
Perform and coordinate PMS start-up activities to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with the local guidelines and SOPs. These include, but are not limited to site and investigator selection, collection and review of critical documents, preparation and submission of dossier for review and approval of relevant authorities.
Provide training on the protocol and proper conduct of PMS studies to investigators and site staff.
Perform monitoring of PMS sites, including the review of data and essential documents, and tracking of data query resolution by sites.
Track enrolment status reports to ensure study stays on track to meet enrolment goals.
Escalate site and PMS related issues, until identified issues are resolved or closed.
Verify adverse event reporting according to the protocol and regulatory requirements.
Perform study tracking and provide regular site status information to PMS SafetyMonitor Manager for each assigned PMS study.
Act as main contact for sites and coordinates all site-related communications.
Facilitates site audits and audit findings resolution together with the sites.
Allowances: Commutation, Housing, Overtime Work etc.
Working Hours: Headquaters (Osaka/ Tokyo) 9:00-17:30,
Production Sites (Osaka/ Yamaguchi) 8:00-16:45,
Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day,
Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Refresh Leave,
Maternity Leave, Childcare Leave, Family Nursing Leave, Philanthropy Leave
Degree in Health Sciences preferred
Previous experience in monitoring PMS or clinical trials preferred
: Conversational level English
Good communication and interpersonal skills.
Ability to proactively predict issues and solve problems.
In-depth knowledge of safety monitoring framework of pharmaceutical industry in general and Takeda in particular in order to apply appropriate standards on PMS studies.
Experience in interacting with all levels of the organization, including senior-level business partners / leaders
Will need to be deployed to monitor desired number of PMS sites in specific regions