Japan Local Case Advisor, GBS Patient Safety

As a Japan Local Case Advisor, you'll be at the heart of safety reporting for Top Pharmaceutical and Rare Disease Unit products in Japan. This pivotal role involves managing Individual Case Safety Reports (ICSRs), ensuring compliance with Japanese regulatory requirements and Top Pharmaceutical pharmacovigilance standards. Based in Bangalore, 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 (only for Japan domestic cases)
• 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