|仕事内容||This position manages the patient safety activities which are integrated into safety programs and marketed products to maximize Patient safety,
Keep compliance with the ICSRs submission to the local authority and Corporate and the aggregate reports to the local authority, Support NDA submissions and respond to inquiries,
Manager of pharmacovigilance system in japan including partnerships
Ensure full compliance with applicable pharmacovigilance regulations in Japan and with
internal requirements Responsible
Support Clinical team for CTD submission and clinical trial management from a safety point of views as needs.
Support to inspection and audit readiness of the affiliates in Japan in full collaboration with Patient Safety and pharmacovigilance QA.
Safety Data Management
Evaluate ICRSs. literature, regulatory intelligence in foreign countries, and report to the local authority according to local regulations,
Report all adverse event/reaction report (spontaneous Health Authorities, literature, etc.), to Global Patient Safety in timely manner,
Evaluate the reportability and submit all qualifying case report and any new information
relevant to the evaluation of the benefit/risk afforded by a product as required by local regulations and Global Patient Safety procedures.
Aggregate Report Management
Where applicable, write Periodic Safety Patient Update Reports (J-PSURs, Unexpected & non-serious ADR aggregate reports and J-DSURs) and other pharmacovigilance reports for local products.
Endure effective communication to global Patient Safety Group or to the Benefit Risk Team of any safety signal/risk identified locally.
Produce Risk Management Plan requested by the local health Authorities.
Interface with all relevant UCB department to get relevant safety information
Product Complaint Management
report to Head of safety group in Patient Safety Japan for informing QC about any complaint
Ensure archiving of all documentation pertinent to a case originating in Japan, Incising data and signed record of oral communications that the local UCB organization has received
At least 8 years so relevant experience for Drug Safety and /or PV is required.
scientific background in CNS and/or immunology helpful
Have Recognized credibility with UCB management and gained the confidence and support of individuals in UCB companies worldwide
Have demonstrated track record in the interpretation and application of international regulations regarding safety reporting
Have a sound knowledge of UCB corporate o\policy regarding safety surveillance.
Have a thorough understanding of the computerized systems to support this function.
Have strong oral and written communication skills as the individual s from diverse cultural backgrounds.
Have strong interpersonal skills, especially in individual leadership and adaptability
Have excellent decision-making skills
Detail oriented to aim for 100% compliance
Experience in change management and scenario planning
Communication with the other functions and senior leadership teams
Solid foundation for making quick, sound decisions, based on limited information
Ability perform trend analysis identify gaps and implement rick mitigation strategy Self starter
To colleague in Japan as well as other colleagues in PVO, PVF, PVP and global PS.
Healthcare professionals, Patient, Consumers, Caregivers Local health authority, National Pharma Association (if allocable) and License partners,
フレックスタイム制 （コアタイム無し） 7.5ｈ×月間所定労働日数で清算
|企業情報||設 立 1988 年
資 本 金 34億9千9百万円
売 上 高 217億円 （2016年）
社 員 数 403名（2016年12月31日現在）