【AstraZeneca】【R&D】Senior Specialist, ペイシェントセーフティ統括部 ペイシェントセーフティオペレーショナルエクセレンス部

Senior Specialist, PS Operational Excellence leads implementation of appropriate operation to ensure PV activities in compliance with GVP/GPSP/GCP regulation with collaboration with internal/external partners.
The Senior Specialist, PS Operational Excellence is responsible for:
o Develop and maintain operation of case processing and reporting safety reports (ICSRs) working with external vendors to ensure regulatory compliance
o Work with case handling vendors collaboratively to keep quality of safety reports by monitoring outputs in daily huddle meeting, operational committee etc.
o Manage cost for case handling vendors with appropriate estimation of number of cases by latest information provided by marketing department and other environmental factors
o Negotiate contents and cost of case handling vendors considering latest business situation
o Lead team of submission/inspection for Re-examination to ensure reports in time for submission target and manage queries by PMDA
o Work for safety activities in clinical trials activities (e.g. DSUR submission and provision of safety information to clinical sites) in collaboration with DO department in R&D
o Manage distribution of safety information like JPI revision in compliance with GVP
o Manage EPPV operation in collaboration with PSS and Commercial dept.
o Maintain and develop local IT systems for Pharmacovigilance activities in collaboration with R&DIT and global PVIT
o Drive integration of Japan case handling process into Global

Essential

• Qualified degree in Pharmacy/ Medical/ Science
• Strategic Influencing - through well-thought-out rationale and effective communication skills, able to influence key decisions
• Communication/negotiation skill
• Business English (required to communicate with Global team verbally)
• Understanding of the PMD Act, relevant regulations, GCP/GVP/GPSP, and guidelines
• Basic knowledge of statistical analysis
• Expertise in medical/pharmaceutical science in general

Desirable

• Analytical Thinking - Logically breaking situations or issues down into their essential elements.
• Leadership skill
• Problem solution skill
• Logical thinking

Career Level : D

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