Manager, Safety

2 weeks ago

Gurgaon, Haryana, India Syneos Health Full time
Job Description

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

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