Safety & PV Specialist I (Japanese Language Expert)

Job Responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
• Assist in the processing of ICSRs as per Standard Operating Procedures (SOPs) and project / program-specific safety plans.
• Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability.
• Enter data into safety database.
• Code events, medical history, concomitant medications, and tests.
• Compile complete narrative summaries.
• Identify missing information, raise queries, and follow up until resolution.
• Generate timely, consistent, and accurate expedited reports per regulatory requirements.
• Maintain safety tracking for assigned activities.
• Perform literature screening and review for safety, drug coding, and MedDRA coding.
• Validate and submit xEVMPD product records, including indication coding using MedDRA.
• Perform manual recoding of un-recoded product and substance terms from ICSRs.
• Identify and manage duplicate ICSRs.
• Handle activities related to SPOR / IDMP.
• Conduct quality review of ICSRs.
• Ensure submission of relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File as per SOP / Sponsor requirements.
• Maintain compliance with SOPs, Work Instructions (WIs), global regulations, GCP, ICH, and GVP guidelines.
• Foster constructive and professional relationships with project team members, internal and external.
• Participate in audits as required.
• Apply safety reporting regulatory intelligence maintained by Syneos Health to safety reporting activities.

Qualifications

Skills Required

Pharmacovigilance, Data Analysis, Risk Assessment, Report Writing, Japanese Language, Sop