Syneos Health is Hiring Safety & PV Specialist I – Japanese Language

Job Responsibilities

• Complete data entry in safety database including writing of adverse event narrative and preliminary assessment of event seriousness and expectedness / listedness as per Reference Safety Information. Documents will be in Japanese Language
• Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
• Should have Japanese language certification(N3) + Any graduation (Science/Non-Science)+ Relevant PV experience or
• Should have Japanese language certification (N3) + Life Science graduation+ Fresher/No PV experience
• The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 3 to 1 will be eligible.
• Person should know to read and write Japanese (Mandatory)
• Role requires the candidate to translate/interpret information from Japanese to English and English to Japanese for teams
• Candidate must have a good grasp over Japanese language
• Preferred having Good Understanding in medical terminology
• Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Power rpoint), email software (Outlook), and spreadsheet software (MS Excel)

Apply HERE