Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.
Post : Safety & PV Specialist II (Japanese Language)
• 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
• Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send request for additional information to the sites/reporter.
• Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
• Forward safety report documents to designated medical reviewer for review.
• Forward completed safety report documents to clients and other relevant parties.
• Foster constructive and professional working relationships with all project team members, internal and external.
• File documents according to project specific requirements (electronically or in hard copy as applicable).
• Ensure case files are compliant with SOPs.
• Interact and communicate effectively with other company departments/functions such as project management field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects.
• Perform literature review as appropriate for Post-Marketing cases.
• Maintain knowledge of legislation, guidelines and regulations relating to safety and PV reporting applicable to countries where Syneoes Health Clinical manages safety responsibilities.
• Provide support for PV Lead with miscellaneous project tasks relating to safety reporting.
• Participate in audits as required/appropriate.
• Any other duties as assigned by manager.
• Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
• The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT N4 or N3 certification 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
• Applicant should be ready to work in Japanese time zone
• Safety Database systems and knowledge of medical terminology preferred.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
• Ability to work independently and in a team environment
• Good communication and interpersonal skills, both written and spoken
Qualification : B.Sc, B. Pharm
Location : Pune
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Safety & PV
End Date : 10th November, 2020
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