Safety & PV Specialist I -Japanese Language expert
Safety & PV Specialist I -Japanese Language expert
Syneos Health
Job description
Syneos Health is hiring a Safety and PV Specialist I with Japanese language skills in Gurugram, offering a great career opportunity for life science, nursing, and pharmacy graduates with JLPT N3 or higher.
Company Description
Syneos Health is a leading life sciences services company built to speed up customer success. It partners with innovators across drug development and commercialization to help them handle complexity and move faster. Over the past 5 years, the company has worked with 94 percent of all novel FDA-approved drugs and over 200 studies across 73000 sites. Its purpose is Driven to Deliver.
Job Summary
This role is for a Safety and PV Specialist I who knows Japanese, based in Gurugram. It is a full-time role with a remote arrangement listed as an exception. The person will process safety case reports, enter data in safety databases, and code medical terms. The role also covers quality review and reporting to regulators. Japanese skills at JLPT N3 or higher are needed.
Key Responsibilities
Enter and track safety case reports, called ICSRs, in the safety systems.
Process and sort ICSRs as per SOPs and project safety plans.
Check each case for completeness, accuracy, and need for reporting.
Enter safety data into databases and code adverse events, medical history, other medicines, and tests.
Write full case summaries and follow up until all needed details are received.
Help send urgent safety reports on time and in line with the rules.
Keep safety tracking records for your assigned work.
Screen and review medical literature, and carry out drug coding and MedDRA coding.
Check and submit product records, including coding of indication terms with MedDRA.
Fix product and substance terms that remain uncoded in cases.
Find and manage duplicate cases.
Support SPOR and IDMP-related work.
Carry out quality reviews of safety cases.
Make sure the right documents go into the Trial Master File and the Pharmacovigilance System Master File.
Follow SOPs, GCP, ICH guidelines, GVP, and global drug and device rules.
Take part in audits when needed.
Educational Qualification
A bachelor's degree in life sciences is needed, or a qualification as a registered nurse or pharmacist.
1 to 2 years of experience in case processing is an added advantage.
Candidates must also hold a JLPT N3 Japanese certificate or higher.
Skills Required
Experience with safety database systems.
Good knowledge of medical terms and MedDRA coding.
Understanding of trials from Phase II to IV and the needs related to safety after the product is on the market.
Knowledge of Good Clinical Practice and Good Vigilance Practice.
Japanese language skills at JLPT N3 level or higher.
Good skills in using Word, Excel, PowerPoint, Visio, and Outlook.
Strong organization, attention to detail, and the ability to set priorities.
Salary Structure
The salary for the Safety & PV Specialist I (Japanese Language Expert) role at Syneos Health in Gurugram typically ranges from ₹5 Lakh to ₹8 Lakh per annum.
Career Development
This job helps you develop skills in global drug safety and handling cases. This job can help you move up to become a safety specialist, a team lead, or a person in a regional safety role as time goes on.
How to Apply
Visit our job portal and search for the Safety and PV Specialist I Japanese Language Expert role at Syneos Health, Gurugram.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.