Job Title: Safety & Pharmacovigilance Specialist II – Japanese Language
Company: Syneos Health
Location: Yerawada, Maharashtra, India
Employment Type: Full-Time
Experience Required: 2–5 years (Pharmacovigilance preferred)
Job ID: 25104313-OTHLOC-5448
Last Updated: December 18, 2025
Syneos Health, a global leader in integrated biopharmaceutical solutions, is hiring a Safety & Pharmacovigilance Specialist II (Japanese Language) to support Japan-specific safety reporting activities. This role is critical for ensuring accurate, compliant, and high-quality pharmacovigilance case processing and regulatory submissions involving Japanese source data.
The position is ideal for professionals with Japanese language proficiency (JLPT N3/N2) and hands-on experience in drug safety, ICSR processing, and global pharmacovigilance operations.
Review safety case data in the Argus safety database, ensuring consistency between English source documents and Japanese entries.
Translate safety information into high-quality, regulatory-compliant Japanese content.
Prepare and author Japanese narratives for Japan-specific safety cases.
Process Japan domestic safety cases, including data entry from Japanese source documents in accordance with local reporting requirements.
Perform pharmacovigilance activities with a primary focus on reading and writing Japanese, including unstructured database fields.
Enter, triage, and process Individual Case Safety Reports (ICSRs) in compliance with SOPs and project-specific safety plans.
Evaluate ICSRs for completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and drug dictionaries.
Compile comprehensive safety narratives and manage follow-ups for missing or queried information.
Support expedited and periodic safety reporting in line with global and local regulations.
Conduct literature screening and safety review activities as required.
Perform xEVMPD submissions, SPOR/IDMP-related activities, and manual recoding of product and substance terms.
Identify and manage duplicate ICSRs and conduct quality reviews of safety cases.
Ensure accurate filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with global SOPs, Work Instructions, ICH-GCP, GVP, and applicable regulatory requirements.
Participate in audits and inspections as needed and collaborate effectively with global project teams.
JLPT N3 certification is mandatory; JLPT N2 preferred.
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a relevant discipline (non-life science graduates with relevant PV experience may be considered).
2–5 years of experience in Pharmacovigilance, Drug Safety, or Clinical Safety Operations preferred.
Working knowledge of safety databases (e.g., Argus) and medical terminology.
Understanding of clinical trial phases (II–IV), post-marketing safety, ICH-GCP, GVP, and global safety regulations.
Proficiency in MS Office applications (Word, Excel, PowerPoint) and standard PV systems.
Advanced Japanese language proficiency with strong Kanji knowledge.
High attention to detail and strong data accuracy skills.
Excellent written communication skills in Japanese and English.
Ability to manage multiple safety cases and meet regulatory timelines.
Strong organizational, analytical, and problem-solving abilities.
Ability to work independently and collaboratively in a global environment.
Work with a global organization involved in the majority of novel FDA- and EMA-approved therapies.
Exposure to large-scale, international pharmacovigilance programs and regulatory environments.
Strong focus on career development, training, and employee well-being through the Total Self culture.
Opportunity to contribute directly to patient safety and global drug developme
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