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Pharmacovigilance

Location: 

Tokyo, Tokyo, Japan

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  64565
 

【募集職種】

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,

【職務内容】

 

 

Major Accountabilities

  • 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.

 

Risk Management

  • 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.

 

Key Interface

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

 

Miscellaneous

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

 

Experience

At least 8 years so relevant experience for Drug Safety and /or PV is required.

scientific background in CNS and/or immunology helpful

 

Specific skills/competences

  • 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

 

Problem Solving

  • Solid foundation for making quick, sound decisions, based on limited information
  • Ability perform trend analysis identify gaps and implement rick mitigation strategy Self starter

 

Major Contact

  • Internal

To colleague in Japan as well as other colleagues in PVO, PVF, PVP and global PS.

 

  • External

Healthcare professionals, Patient, Consumers, Caregivers Local health authority, National Pharma Association (if allocable) and License partners,

 

 

 

【勤務地】

東京本社(西新宿)

 

【給与】

年俸制

 経験・能力等を考慮の上、決定

 社内規定に準じます 

 成果に応じて昇給あり(年1回)

 通勤交通費別途支給

 

【福利厚生】

退職年金・団体生命保険・定期健診・各種社会保険・財形財蓄制度

 永年勤続表彰・クラブ活動・英語学習補助

 

【休日休暇】

週休2日制(土・日)

 祝日・夏季休暇・年末年始休暇・有給休暇・慶弔休暇・特別休暇

 

【勤務時間】

9:30-18:00

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

 
 


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