药物警戒

Introduction to role
Are
you ready to make a difference in patient safety? As a Japan Local Case
Advisor, you'll be at the heart of safety reporting and Rare Disease Unit
products in Japan. This pivotal role involves managing Individual Case Safety
Reports (ICSRs), ensuring compliance with Japanese regulatory requirements and pharmacovigilance
standards. , you'll need proficiency in English and Japanese,
and may work in Japan's time zone. You'll support the GBS PS function under the
mentorship of Case Intake Team Managers, delivering routine activities
independently and resolving moderate complexity problems. Are you up for the
challenge?
Accountabilities

• Case Intake（Submission）
• Accept, validate, and
  perform preliminary assessment of local safety cases, including phone
  calls with reporters
• Handle personal
  information and confidential data per regulatory guidelines
• Implement routine quality
  checks and undertake manual follow-up if required
• Collaborate with internal
  partners to clarify or triage case information
• Flag urgent or reportable
  cases for blocking issue resolution
• Local Data Entry
  (applicable for both Japan domestic cases and Foreign cases)
• Perform data entry into
  relevant safety database systems with high accuracy
• Connect with internal
  collaborators to resolve data entry issues
• Request follow-up
  information using specific product/event-related questionnaires
• Audit / Inspection
  Readiness
• Implement Corrective and
  Preventative Actions for local non-compliance
• Follow SOPs for filing and
  archiving safety documentation
• Support team in audits and
  regulatory authority inspections
• Regulatory Compliance
• Ensure adherence to
  Japanese regulatory standards for ICSRs and AE reporting
• Call out urgent or
  high-risk cases following established procedures
• Quality Management System
  (QMS)
• Contribute to effective
  operational implementation of the QMS
• Maintain knowledge of Japanese
  product portfolio and regulation changes
• General / Others
• Perform Peer review and
  ad-hoc project specific tasks as assigned
• Collaborate on PV aspects
  related to Organised Data Collection Programmes

Essential
Skills/Experience

• Degree qualified or possessing
  equivalent experience
• Japanese language
  proficiency: N2 or higher for listening, writing and speaking (only for
  Japan domestic cases); N3-N1 for reading Japanese Kanji characters
  particularly in medical terminology
• English language
  proficiency: A2 Waystage based on CEFR
• Life-science background
• 1–2 years of experience in
  local data entry in a safety database
• High attention to detail
  and ability to identify personal/confidential information (PII)
• Cross functional
  collaborative approach
• Effective and lateral
  thinking
• Problem solving
• Excellent written and
  verbal communication skills

Desirable Skills/Experience

• Degree qualified in Pharmacy, Medical, or Science, or with
  equivalent experience
• Pharmacovigilance knowledge excellence
• Experience with ARGUS
• Experience in local case intake
• Familiarity with Good Pharmacovigilance Practice / Good
  Clinical Practice and relevant regulations
• Influencing, and Conflict Resolution skills
• Basic knowledge of standard office software packages (Word,
  Excel)
• Experience working with multinational
  teams
• Medical knowledge in
  company Therapeutic Areas
• Project management
• Ability to quickly develop
  good understanding of AE and drug coding conventions (MedDRA, WHO-DD)
• Successful participation
  in above-market projects
• Audit & Inspection
  experience