Job Title: Safety & Pharmacovigilance Specialist I (Japanese Language)
Location: Pune, India
Job ID: 25104312
Employment Type: Full-Time
Industry: Pharmacovigilance | Drug Safety | Clinical Research | CRO
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I (Japanese Language) to join its Drug Safety and PV operations team in Pune, India. This role is ideal for professionals with strong Japanese language proficiency and foundational experience in pharmacovigilance, ICSR processing, or clinical safety operations.
As a global biopharmaceutical solutions organization operating in over 110 countries, Syneos Health supports pharmaceutical and biotechnology companies in ensuring regulatory-compliant safety reporting across clinical and post-marketing programs.
The Safety & PV Specialist I will support Japanese pharmacovigilance case processing, safety data review, ICSR management, and regulatory-compliant reporting. The role requires strong written Japanese proficiency, particularly in translating and drafting medically accurate safety narratives for Japan-specific reporting requirements.
This opportunity is suited for candidates looking to build expertise in:
Pharmacovigilance (PV) Case Processing
Individual Case Safety Report (ICSR) Management
Japanese Regulatory Safety Reporting
MedDRA Coding & Drug Safety Databases
GVP, ICH-GCP & Post-Marketing Safety Compliance
Review safety case information in the Argus safety database, ensuring consistency between English source data and Japanese entries.
Translate safety data into accurate, regulatory-compliant Japanese language narratives.
Prepare and write Japanese narratives for Japan-specific regulatory submissions.
Handle Japan domestic safety cases, including structured and unstructured data entry from Japanese source documents.
Demonstrate advanced kanji proficiency and the ability to interpret clinical and safety terminology accurately.
Process Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans.
Triage ICSRs and evaluate data for completeness, accuracy, and reportability.
Enter case data into safety databases and perform:
MedDRA coding
Drug coding
Medical history and concomitant medication coding
Compile detailed narrative summaries.
Identify missing information, initiate queries, and follow up for resolution.
Ensure timely submission of expedited safety reports per regulatory timelines.
Perform literature screening and safety review activities.
Support validation and submission of xEVMPD product records, including MedDRA coding of indication terms.
Conduct manual recoding of un-coded product and substance terms from ICSRs.
Identify and manage duplicate ICSRs.
Support SPOR / IDMP-related activities.
Conduct quality review of ICSRs.
Ensure required documentation is filed in:
Trial Master File (TMF) for clinical trials
Pharmacovigilance System Master File (PSMF) for post-marketing programs
Maintain compliance with global drug safety regulations including ICH-GCP, GVP, and applicable regional regulatory standards.
Participate in internal and external audits as required.
0–3 years of experience in Pharmacovigilance, Drug Safety, or Clinical Safety Operations.
Prior experience in ICSR processing or safety database management is preferred.
Experience with Argus or similar safety databases is advantageous.
Candidates with prior exposure to Japanese safety reporting standards are highly preferred.
Bachelor’s degree in Life Sciences (Pharmacy, Biotechnology, Nursing, Medicine, or related field) preferred.
Non-life science graduates with relevant pharmacovigilance experience may also be considered.
JLPT N3 certification is mandatory.
JLPT N2 certification is preferred.
Strong written Japanese proficiency, especially for medical narrative writing.
Minimal speaking requirement; role primarily involves reading and writing Japanese.
Strong knowledge of medical terminology.
Understanding of clinical trial phases (Phase II–IV) and post-marketing safety requirements.
Familiarity with ICH-GCP, GVP, and global pharmacovigilance regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Ability to manage multiple tasks and meet strict regulatory timelines.
High attention to detail and data accuracy.
Strong written and interpersonal communication skills.
Office-based role in Pune, India.
Global pharmacovigilance operations supporting Japan and international markets.
Structured safety processes aligned with global regulatory frameworks.
Collaborative and compliance-focused work culture.
This role provides foundational experience in:
Japanese Pharmacovigilance Operations
Global ICSR Processing
Regulatory Safety Reporting
Risk Management & Signal Detection Support
Potential career progression includes:
Safety & PV Specialist II
Senior Drug Safety Associate
Pharmacovigilance Team Lead
Safety Operations Manager
Syneos Health has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years. With more than 29,000 employees globally, the organization supports clinical trials across 73,000+ sites and hundreds of thousands of patients worldwide.
If you are a Japanese language-certified professional seeking a career in Pharmacovigilance and Drug Safety, this opportunity in Pune offers exposure to global safety operations and regulatory reporting standards.
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