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Manager, Safety & Pv (Japanese Language Professional)

0-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Manager, Safety & Pharmacovigilance (Japanese Language Professional)

Company:

Syneos Health

Updated:

April 11, 2025

Location:

Gurugram, India (DLF Downtown)

Job ID:

25002243


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization with over 29,000 employees across 110 countries. Their collaborative, agile approach supports clients in bringing new therapies to market efficiently. The company is committed to creating a diverse, inclusive, and empowering workplace through its "Total Self" culture.


Why Work at Syneos?

  • Clear career progression and development plans

  • Supportive leadership and training

  • Inclusive culture with focus on well-being

  • Recognition and reward systems

  • Opportunities to make a global impact


Job Responsibilities

Team & Project Management

  • Manage direct reports: hiring, training, performance, and workload assignments

  • Review team output quality and ensure alignment with scope and Safety Management Plans

  • Lead Safety and PV services in assigned projects

  • Monitor budgets, approve invoices, ensure compliance with contractual deliverables

  • Coordinate across internal departments for safety reporting and issue resolution

  • Provide sponsors with project updates and manage timecard approvals

Departmental Leadership

  • Support SOP development and review

  • Evaluate and improve departmental processes

  • Participate in business development and bid defense meetings

  • Ensure safety portions of proposals, protocols, and CRFs are accurate

  • Approve project-specific safety budgets

Compliance & Training

  • Ensure adherence to SOPs, GCP, ICH, GVP modules, and other regulations

  • Conduct training and mentorship for Safety team members

  • Prepare for and support audits and inspections

  • Contribute to corrective and preventive action plans

Other

  • Escalate resourcing issues to senior management as needed

  • Perform other related duties as assigned

  • Minimal travel may be required


Qualifications

  • Language:
    JLPT N3 or higher Japanese language certification required

  • Education:
    BA/BS in biological sciences, healthcare, nursing, or related field—or equivalent experience

  • Experience & Skills:

    • Demonstrated leadership and project management capabilities

    • CRO experience and therapeutic area expertise preferred

    • Familiarity with financial analysis and budgeting

    • Strong computer skills (Microsoft Office Suite, Visio, Outlook, TeamShare)

    • Effective written and verbal communication skills

    • Ability to work both independently and within matrix teams

    • Strong decision-making, organizational, and multitasking abilities


Additional Info

The role’s responsibilities may evolve with company needs. Syneos is committed to equal opportunity, reasonable accommodation, and compliance with global employment regulations.