Syneos Health is hiring a Japanese Language Expert – Safety & Pharmacovigilance (PV) Specialist for a remote position based in India. This role is critical in managing drug safety and pharmacovigilance activities, ensuring compliance with global regulations.
Key Details
- Company: Syneos Health
- Job Role: Japanese Language Expert – Safety & PV Specialist
- Experience: 0+ years (Freshers can apply)
- Location: Remote (Hiring office in India)
- Openings: 3
- Employment Type: Full-time, Permanent
Job Description
Key Responsibilities
- Workflow Coordination: Ensure smooth project delivery by managing team workload and escalating issues promptly.
- Safety & PV Risk Management: Assist in identifying and mitigating pharmacovigilance risks.
- Regulatory Compliance: Process Individual Case Safety Reports (ICSRs) in compliance with global regulations (ICH-GCP, GVP).
- Data Entry & Quality Control: Enter and validate safety data in pharmacovigilance databases, ensuring accuracy.
- Medical Coding: Perform MedDRA coding for adverse events, medical history, and concomitant medications.
- Safety Reporting: Generate and submit expedited and periodic safety reports as per regulatory requirements.
- Audit & Inspection Support: Participate in audits and ensure compliance with Trial Master File (TMF) requirements.
- Training & Mentoring: Provide training to investigators and team members on safety reporting.
Skills & Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- Language Proficiency: Fluency in Japanese (reading, writing, speaking) is mandatory.
- Technical Skills:
- Experience with safety databases (Argus, ARISg, VigiFlow, etc.)
- Knowledge of medical terminology
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Regulatory Knowledge: Understanding of ICH-GCP, GVP, and global pharmacovigilance regulations
- Soft Skills:
- Strong communication & organizational skills
- Ability to work independently and in a team
- High attention to detail
About Syneos Health
Syneos Health (Nasdaq: SYNH) is a leading global contract research organization (CRO) offering clinical, commercial, and consulting solutions to biopharmaceutical companies. With a presence in over 110 countries, Syneos Health accelerates drug development and commercialization through integrated services.
Why Join Syneos Health?
- Global Exposure: Work with top pharmaceutical companies worldwide.
- Career Growth: Opportunities for professional development in pharmacovigilance and drug safety.
- Remote Work Flexibility: Work from anywhere in India.
How to Apply
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