PRINCIPAL / ASSOCIATE DIRECTOR / SOLUTION LEAD
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About our client:
Our client brings together Pharmacovigilance expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across Medical Affairs, Regulatory and Safety functions. Our client solutions free up responsible personnel within Pharma companies to execute their stated responsibilities while staying true to the laws of the land, and ultimately achieving a balance between compliance and managing business risks. Their solutions are agile, flexible, and scalable, developed using advanced technologies that enable them to serve large and small organizations, both in developed and emerging markets.
Our client is committed to bringing focus to things that really matter for advancing patient outcomes. Their solutions are agile, flexible and scalable, developed using advanced technologies that enable us to serve large and small organizations, both in developed and emerging markets.
Requirements
Principal / Associate Director/ Solution Lead (Japanese)
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 knowledge of Oracle Argus Safety or other PV/Safety systems.
- Experience in installing/configuration/validation of Argus Safety and customizations.
- Manage and approve daily Argus configuration changes as the database controller via the Argus Safety Change Management Standard Operating Procedures (SOP).
- Attend and/or lead the client Argus Safety Governance Committee (ASGC) meeting as a (PV) director delegate to provide oversight and guidance on changes, Argus projects and ongoing issues.
- 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).
- Develop, update, and maintain dedicated templates (including team member training) on Tenant Configuration, Business Configurations, Code List changes, and User Permissions.
- Develop, update, and maintain dedicated 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.
- Good understanding of regulations.
Behavioral 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.