BA/Validation/Business Solution Lead

Key Role and Responsibilities:

Fluent in Japanese language (speaking, as well as reading and writing). Able to translate English to Japanese and vice versa. JLPT N1-N2 certification is preferred.
Excellent functional knowledge of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
Experience in installing/ configuration/ validation of PV Safety Systems like Oracle Argus Safety, Lifesphere Multivigilance etc.
Attend all meetings as a PV Systems subject matter expert (SME).
Participate in and contribute to safety system design requirement specifications for the safety database as a PV Systems SME.
Provide vendor/client oversight of report development: Compliance, Aggregate, Signal Detection, Data Mining, Key Performance Indicators (KPIs).
Review and provide feedback on templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions.
Review and provide feedback on work instructions associated with ongoing safety database maintenance projects, including upgrades, Medical Dictionary for Regulatory Activities (MedDRA) / WHO Drug versioning, direct Electronic Submission Gateway (ESG) setup, etc.
Primary lead for deliverables and participate in audits and inspections of the dedicated PV System.
Solid understanding of pharmacovigilance principles and practices.

Behavioural Skills:

Ability to multi-task, self-directed and independently handle multiple global stakeholders.
Ability and willingness to be flexible, adapting to the demands of the customers.
Exceptional interpersonal skills to interact with a variety of stakeholders and foster cross-functional/cultural teamwork.
Ability to work in a fast-paced environment, maintaining flexibility and performing at a high level when faced with time constraints.
Strong critical thinking skills to evaluate alternatives and present solutions consistent with business objectives.