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Manager, Safety & PV (Japanese Language Professional)
ConfidentialGurgaon / Gurugram8 days ago
Job descriptionN3 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
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 :
Skills Required
Pharmacovigilance, Risk Assessment, Safety Management, Quality Assurance, Project Management
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Safety Manager • Gurgaon / Gurugram