Safety and Pharmacovigilance Specialist I (Japanese Language)
Location: Pune, India
Job ID: 25104312
Company: Syneos Health
Industry: Pharmacovigilance / Drug Safety / Clinical Research
Employment Type: Full-Time
Experience Required: 0–2 Years (Pharmacovigilance or Drug Safety Preferred)
Updated: January 29, 2026
Job Overview
Syneos Health is seeking a Safety and Pharmacovigilance Specialist I with Japanese language expertise to support global drug safety operations and regulatory compliance. This role focuses on Individual Case Safety Report (ICSR) processing, safety data review, Japanese medical narrative writing, and regulatory documentation management in accordance with global pharmacovigilance standards.
This position is ideal for candidates with strong Japanese language proficiency and foundational knowledge of pharmacovigilance, clinical trials, or life sciences. The role involves handling Japan-specific safety cases, safety database management, and regulatory reporting activities within a highly collaborative global environment.
Syneos Health is a globally recognized biopharmaceutical solutions organization dedicated to accelerating clinical development, improving patient outcomes, and delivering innovative healthcare solutions.
Key Responsibilities
Review safety case data in Argus safety database, ensuring consistency between English source data and Japanese entries
Translate clinical and safety information into accurate, regulatory-compliant Japanese documentation
Prepare Japanese safety narratives for Japan-specific regulatory reporting requirements
Process Japan domestic safety cases and perform data entry from Japanese source documents
Handle medical narrative documentation in structured and unstructured safety database fields
Assist in processing Individual Case Safety Reports (ICSRs) in compliance with SOPs and safety plans
Perform case triage and evaluate safety data for completeness, accuracy, and reportability
Code adverse events, medical history, concomitant medications, and laboratory tests
Compile narrative summaries and follow up on missing or unclear information
Support timely and accurate expedited safety reporting in accordance with regulatory requirements
Maintain safety tracking systems for assigned pharmacovigilance activities
Perform literature screening and review for drug safety monitoring
Conduct MedDRA coding and maintain drug dictionaries
Validate and submit xEVMPD product records and code indication terms
Identify and manage duplicate ICSRs and perform manual data recoding where required
Support SPOR and IDMP-related regulatory activities
Perform quality review and validation of safety data and ICSRs
Ensure documentation submission to Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with global pharmacovigilance regulations, GCP, ICH guidelines, and GVP standards
Participate in audits and regulatory inspections as required
Collaborate with internal and external stakeholders across global project teams
Eligibility Criteria and Qualifications
Bachelor’s degree in Life Sciences or relevant field; equivalent experience considered
Mandatory JLPT N3 certification; JLPT N2 certification preferred
0–2 years of experience in pharmacovigilance, drug safety, or related domain preferred
Strong Japanese reading and writing proficiency with advanced knowledge of Kanji
Knowledge of safety database systems and medical terminology
Understanding of clinical trial processes (Phases II–IV) and post-marketing safety requirements
Knowledge of ICH GCP, GVP, and global pharmacovigilance regulations
Experience in safety data processing, ICSR handling, or regulatory reporting preferred
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools
Strong attention to detail with high accuracy in documentation and reporting
Excellent communication, organizational, and multitasking skills
Ability to work independently and collaboratively in a team environment
Preferred Skills and Competencies
Background in pharmacovigilance operations or clinical safety reporting
Experience with MedDRA coding and regulatory safety databases
Understanding of drug development and regulatory processes
Strong analytical and problem-solving skills
Effective time management and ability to meet strict deadlines
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization with over 29,000 employees across 110 countries. The company combines clinical development, medical affairs, and commercial expertise to help customers accelerate therapy delivery and improve patient outcomes. Over the past five years, Syneos Health has contributed to 94 percent of novel FDA-approved drugs and 95 percent of EMA-authorized products, supporting more than 200 studies across 73,000 sites and over 675,000 clinical trial patients worldwide.
Syneos Health promotes professional development, diversity, and a collaborative work environment focused on innovation, regulatory excellence, and global healthcare advancement.
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Siliguri |Illinois :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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