Safety & Pharmacovigilance Specialist I – Japanese Language
Updated: Yesterday
Location: Gurgaon, Haryana, India
Job ID: 25104312
Employment Type: Full-Time
About Syneos Health®
Syneos Health® is a leading global biopharmaceutical solutions organization that accelerates customer success by integrating clinical development, medical affairs, and commercialization expertise. With a patient-centric operating model and presence across more than 110 countries, Syneos Health supports the development and delivery of innovative therapies worldwide.
Position Overview
The Safety & Pharmacovigilance Specialist I – Japanese Language is responsible for supporting global and Japan-specific pharmacovigilance activities, with a primary focus on Japanese-language safety case processing, translation, and regulatory-compliant reporting. This role requires strong written Japanese proficiency, pharmacovigilance knowledge, and the ability to process individual case safety reports (ICSRs) in accordance with global and Japan-specific regulatory requirements.
The position is ideal for candidates with early to mid-level pharmacovigilance experience and advanced Japanese language skills seeking to work in a global drug safety environment.
Key Responsibilities
Japanese Language and Safety Case Processing
Review safety case information in the Argus safety database, ensuring consistency between English source data and Japanese-language entries
Translate clinical and safety-related information into accurate, high-quality Japanese for regulatory-compliant reporting
Prepare and author Japanese narratives for Japan-specific safety cases in alignment with local regulatory requirements
Perform data entry and processing of Japan domestic safety cases using Japanese source documents
Pharmacovigilance Operations
Process Individual Case Safety Reports (ICSRs) in compliance with applicable SOPs, project-specific safety plans, and regulatory timelines
Triage ICSRs and assess case data for completeness, accuracy, and regulatory reportability
Enter, code, and update safety data, including adverse events, medical history, concomitant medications, and laboratory tests
Compile complete narrative summaries and follow up on data queries until resolution
Regulatory and Data Management Activities
Perform literature screening and safety review activities, including MedDRA coding and drug dictionary maintenance
Support validation and submission of xEVMPD product records, including MedDRA coding of indication terms
Conduct manual recoding of product and substance terms arising from ICSRs, as required
Identify and manage duplicate safety cases
Support activities related to SPOR and IDMP compliance
Perform quality review of ICSRs and maintain safety tracking for assigned activities
Compliance and Collaboration
Ensure all safety documentation is filed in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) in accordance with company and sponsor requirements
Maintain compliance with global and local SOPs, Work Instructions, ICH GCP, GVP, and applicable drug safety regulations
Participate in audits and inspections as required
Apply Syneos Health regulatory intelligence to daily safety reporting activities
Foster professional and collaborative working relationships with internal and external stakeholders
Required Qualifications and Experience
Education
Bachelor’s degree in life sciences or a related discipline
Candidates from non-life science backgrounds with relevant pharmacovigilance experience will also be considered
Experience
0–2 years of experience in pharmacovigilance, drug safety, or a related medical or life sciences role
Prior experience in safety case processing or ICSR handling is preferred
Language Requirements
Mandatory JLPT N3 certification
JLPT N2 certification strongly preferred
Strong written Japanese proficiency, including advanced Kanji knowledge, with the ability to interpret medical and clinical terminology accurately
Technical and Professional Skills
Working knowledge of safety databases (e.g., Argus) and medical terminology
Understanding of clinical trial processes (Phases II–IV) and/or post-marketing safety requirements
Familiarity with ICH GCP, GVP, and global pharmacovigilance regulations
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint), Outlook, and collaborative content management tools
Strong attention to detail, organizational skills, and ability to manage multiple priorities
Ability to work independently as well as collaboratively within cross-functional teams
Effective written and verbal communication skills
Why Join Syneos Health?
Opportunity to work on Japan-focused and global pharmacovigilance programs
Exposure to international regulatory environments and safety operations
Structured training, career development, and mentorship opportunities
Inclusive and supportive workplace culture through the Total Self initiative
Proven global impact, including contributions to:
94% of novel FDA-approved drugs
95% of EMA-authorized products
Over 200 clinical studies worldwide
Additional Information
Responsibilities may vary based on project and business needs
Equivalent combinations of education, skills, and experience will be considered
This role does not constitute an employment contract
Syneos Health is an equal opportunity employer and complies with all applicable global employment and accessibility regulations
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