Safety & Pharmacovigilance Specialist II – Japanese Language
Job Requisition ID: 25104313
Employment Type: Full-Time
Work Mode: Office-Based
Locations: Gurugram | Hyderabad | Pune, India
Experience Required: 3–6 Years
Function: Drug Safety | Pharmacovigilance | ICSR Processing | Japanese Medical Translation
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercialization. With operations across 110 countries and a workforce of over 29,000 professionals, Syneos Health partners with leading life sciences companies to accelerate patient-focused innovation and regulatory excellence.
Role Overview
Syneos Health is seeking a Safety & PV Specialist II (Japanese Language) to support Japan-specific pharmacovigilance activities. This role is ideal for professionals with strong Japanese reading and writing proficiency, experience in ICSR processing, and a solid understanding of global and Japan-specific safety regulations.
The position focuses primarily on Japanese medical translation, narrative writing, and safety case processing, ensuring regulatory-compliant submissions for Japan health authorities.
Key Responsibilities
Japanese Safety Case Processing & Translation
Review safety case data in the Argus safety database and ensure consistency between English source documents and Japanese entries
Translate safety case information into high-quality, regulatory-compliant Japanese for Japan submissions
Prepare and author Japanese narratives for Japan-specific ICSRs
Handle domestic Japan safety cases, including data entry from Japanese source documents in compliance with local reporting requirements
Perform work primarily involving reading and writing Japanese, including unstructured medical narrative fields
Pharmacovigilance Operations
Process Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans
Perform case triage, data entry, MedDRA coding, medical history and concomitant medication coding
Compile complete and accurate narrative summaries and follow up on queries to resolve data gaps
Support timely preparation and submission of expedited safety reports in compliance with global regulations
Maintain safety tracking and documentation for assigned activities
Literature & Data Management
Conduct literature screening and review for safety-relevant information
Support drug coding, MedDRA dictionary maintenance, and duplicate case management
Validate and submit xEVMPD product records, including MedDRA indication coding
Perform manual recoding of product and substance terms arising from ICSRs
Support SPOR / IDMP-related activities
Quality, Compliance & Collaboration
Perform quality review of safety cases and deliverables
Ensure submission of all required documents to TMF and Pharmacovigilance System Master File (PSMF)
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP modules, and global/local safety regulations
Participate in audits and inspections as required
Foster effective working relationships with internal teams and external stakeholders
Education & Experience Requirements
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline
Candidates from non-life science backgrounds with relevant pharmacovigilance experience will also be considered
Experience:
3–6 years of experience in Pharmacovigilance, Drug Safety, or ICSR processing
Prior experience handling Japan safety cases or Japanese literature review is strongly preferred
Experience with safety databases such as Argus is desirable
Language Requirements:
JLPT N3 certification is mandatory
JLPT N2 certification is strongly preferred
Advanced Japanese reading and writing proficiency, including strong Kanji knowledge
Key Skills & Competencies
Strong understanding of global and Japan-specific pharmacovigilance regulations
Excellent Japanese medical writing and translation skills
Knowledge of clinical trial processes (Phases II–IV) and post-marketing safety requirements
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and safety databases
High attention to detail with strong organizational and time management skills
Ability to work independently and collaboratively in a global team environment
Excellent written and interpersonal communication skills
Why Join Syneos Health
Exposure to global and Japan-focused safety programs
Structured career growth and continuous learning opportunities
Inclusive, diverse, and people-centric work culture
Opportunity to work on innovative therapies with global regulatory impact
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and is committed to providing an inclusive workplace in compliance with applicable employment legislation.
Apply now on thepharmadaily.com to advance your career in Japanese Pharmacovigilance and Drug Safety with a leading global CRO.
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