Safety & PV Specialist I (Japanese Language) — Syneos Health
Job Overview
Entry-level to developing Pharmacovigilance (PV) role focused on Japanese-language safety case processing, data entry, and regulatory-compliant reporting in clinical and post-marketing environments.
Location: Pune, India (Hybrid/Office-based depending on assignment)
Job ID: 25105524
Job Family: Pharmacovigilance & Safety
Employment Type: Full-time
Key Responsibilities
1. Japanese Safety Case Processing
Review ICSRs (Individual Case Safety Reports) in Argus safety database
Ensure consistency between English source data and Japanese entries
Translate safety data into accurate Japanese for regulatory reporting
Prepare Japanese narratives for Japan-specific cases
Handle Japan domestic safety cases from Japanese source documents
2. Data Entry & Case Management
Enter and track ICSRs in safety databases
Triaging cases for completeness, accuracy, and regulatory reportability
Code medical events, medical history, drugs, and lab tests (MedDRA coding)
Identify missing information and resolve queries
3. Regulatory Compliance & Reporting
Ensure compliance with SOPs, GVP, ICH guidelines, and local regulations
Support expedited safety reporting timelines
Maintain safety tracking systems and documentation (TMF/PV Master File)
Support audits and inspection readiness
4. Quality & Review Activities
Perform quality review of ICSRs
Identify and manage duplicate cases
Support validation of xEVMPD product records
Assist in manual recoding of safety data where required
5. Literature & Safety Support
Conduct literature screening for safety information
Support drug dictionary and MedDRA maintenance
Assist SPOR / IDMP-related activities
Required Qualifications
Education
Bachelor’s degree in Life Sciences or related field
Non-life science degrees acceptable with relevant experience
Language Requirements
Mandatory: JLPT N3 certification
Preferred: JLPT N2 certification
Experience & Skills
Pharmacovigilance experience preferred
Knowledge of safety databases (Argus preferred)
Understanding of medical terminology
Familiarity with clinical trial phases (II–IV) and post-marketing safety
Strong attention to detail and accuracy
Ability to manage multiple tasks and meet deadlines
Technical Skills
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Safety databases (Argus or equivalent)
Internet-based research tools
Document management systems (e.g., Team Share)
Soft Skills
Strong written and verbal communication
Ability to work independently and in teams
Good organizational and prioritization skills
High level of accuracy and compliance mindset
Key Job Impact
Supports pharmacovigilance safety surveillance for Japan market
Ensures regulatory-compliant reporting of adverse events
Contributes to patient safety and drug lifecycle monitoring
Plays a role in global clinical safety operations
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