Manager, Safety & PV (Japanese Language Professional)

Job Responsibilities:

• Line management including transfers, hiring, utilization, terminations, training, performance appraisals, and employee counseling
• Advise staff on administrative policies, procedures, technical issues, and project prioritization
• Assign project work and review workloads for direct reports
• Monitor quality of work and efficiency of team members per Safety Management Plan
• Manage Safety and Pharmacovigilance projects, ensuring adherence to study budgets and contractual obligations
• Coordinate with Finance for customer invoicing and approve project time cards
• Provide sponsors with project updates and reports
• Collaborate with internal departments to ensure timely safety reporting and issue resolution
• Develop, review, and approve departmental SOPs and Safety Management Plans
• Evaluate processes for efficiency and effectiveness, recommending improvements
• Participate in process development and departmental function improvements
• Support business development efforts, including bid defense meetings and proposal reviews
• Review clinical safety sections of protocols and Case Report Forms (CRFs)
• Maintain compliance with SOPs, WIs, global regulations, GCP, ICH, and GVP guidelines
• Identify, prepare, and deliver training for Safety team members and other departments
• Mentor Safety team members and manage resourcing needs/issues
• Participate in audits/inspections and ensure inspection readiness
• Participate in quality investigations and implement corrective/preventive actions
• Perform other assigned duties, with minimal travel as required

Qualifications:

• N3 or above certified (JLPT) Japanese Language professional
• BA/BS in biological sciences, nursing, or related discipline
• Progressive responsibility with demonstrated leadership and project management experience
• CRO experience in therapeutic specialties preferred
• Working knowledge of financial budgets and analysis tools preferred
• Proficiency in Microsoft Office Suite, Visio, Outlook, TeamShare, and internet tools
• Excellent oral, written, and interpersonal communication skills with strong presentation abilities
• Ability to build effective client and team relationships
• Flexibility, adaptability, and ability to work independently or in a matrix team environment
• Strong decision-making skills and ability to manage multiple priorities in a dynamic environment