Syneos Health Hiring for Safety & PV Specialist I (Japanese )

Syneos Health is hiring for the position of Safety & PV Specialist I – Japanese Language Expert in Gurugram, India. This is a full-time opportunity with a remote work arrangement listed as “Remote (Exception).” Candidates with a life sciences background, pharmacovigilance knowledge, safety database experience, and Japanese language proficiency with at least JLPT N3 certification are eligible to apply.

The role involves Individual Case Safety Report (ICSR) processing, safety data management, medical coding, quality review, regulatory reporting, and pharmacovigilance documentation.

Job Details

Position: Safety & PV Specialist I – Japanese Language Expert

The selected candidate will support pharmacovigilance operations, including ICSR processing, safety database entry, medical coding, literature screening, regulatory submissions, and quality review. The position requires knowledge of applicable pharmacovigilance regulations, clinical trial processes, and safety reporting requirements.

Key Responsibilities

• Enter and track Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and tracking systems.
• Process and triage ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
• Evaluate safety case data for completeness, accuracy, and regulatory reportability.
• Enter safety information into databases and code adverse events, medical history, concomitant medications, and tests.
• Prepare complete narrative summaries and follow up on queries until the required information is obtained.
• Assist with timely and accurate expedited safety reporting in accordance with applicable regulatory requirements.
• Maintain safety tracking records for assigned activities.
• Perform literature screening and review, drug coding, drug dictionary maintenance, and MedDRA coding as required.
• Validate and submit xEVMPD product records, including indication-term coding using MedDRA.
• Manually recode product and substance terms that remain uncoded in ICSRs.
• Identify and manage duplicate ICSRs.
• Support activities related to SPOR and IDMP.
• Conduct quality reviews of ICSRs.
• Ensure relevant documentation is submitted to the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File for post-marketing programs, as applicable.
• Follow applicable SOPs, work instructions, GCP, ICH guidelines, Good Pharmacovigilance Practices (GVP), and global drug, biologic, and device regulations.
• Participate in audits as required and apply relevant safety reporting regulatory intelligence.

Eligibility and Qualifications

Candidates applying for the Syneos Health Safety & PV Specialist I position should meet the following requirements:

• Bachelor’s degree in Life Sciences, or qualification as a registered nurse or pharmacist, or equivalent education and experience.
• At least JLPT N3 Japanese language certification.
• Experience with safety database systems.
• Knowledge of medical terminology.
• Understanding of Phase II–IV clinical trials and/or post-marketing safety requirements.
• Knowledge of ICH Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and safety and pharmacovigilance regulations.

Required Skills

• Individual Case Safety Report (ICSR) processing and quality review.
• Pharmacovigilance and safety database operations.
• Medical terminology and MedDRA coding.
• Drug coding and safety data management.
• Japanese language proficiency with JLPT N3 certification or higher.
• Microsoft Word, Excel, PowerPoint, Visio, and Outlook.
• Team collaboration and professional communication.
• Organization, attention to detail, and task prioritization.
• Ability to manage multiple tasks and meet deadlines.
• Ability to work independently and collaboratively.