Safety & PV Specialist (Japanese Language)
Safety & PV Specialist (Japanese Language)
Syneos Health
Job description
Syneos Health is hiring a Safety and PV Specialist with Japanese language skills in Gurugram, Pune, Hyderabad, or remote, offering a great career opportunity for life science, nursing and pharmacy graduates with JLPT N3 or higher.
Company Description
Syneos Health is a company that provides complete solutions for biopharmaceutical businesses. It takes ideas from work, medical affairs, and commercial areas and turns them into actual results. The company has 29,000 employees who work in 110 countries as one team. It helps people grow in their careers by offering training, supportive managers, recognition from coworkers, and a total rewards program. Syneos has a vision of shortening the distance from lab to life.
Job Summary
This role is for a Safety and PV Specialist who speaks Japanese. The job is available in Gurugram, Pune, and Hyderabad. Also offers a remote option. The Safety and PV Specialist will read safety case reports. Then enter the information into safety databases. The person will also code terms. In addition, the Safety and PV Specialist must perform quality checks. Prepare reports for regulators. Japanese language 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 case summaries and follow up until all needed details are received.
Help send urgent safety reports on time and in line with the rules.
Screen and review medical literature, and do drug and MedDRA coding.
Find and manage duplicate cases.
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.
Equal education and experience may also be accepted.
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 clinical trials and post-marketing safety needs.
Knowledge of GCP, GVP and pharmacovigilance rules.
Japanese language skills at JLPT N3 or higher.
Good use of Word, Excel, PowerPoint and Outlook.
Strong organization, attention to detail, and ability to set priorities.
Clear communication and teamwork.
Salary Structure
The average annual salary of Safety and PV Specialist (Japanese Language) at Syneos Health typically ranges from ₹5 Lakhs to ₹7 Lakhs per year.
Career Development
This role builds skills in global drug safety and case processing. The rare Japanese language edge is prized in pharmacovigilance. Over time, you can grow into a safety specialist, team lead, or regional safety role.
How to Apply
Visit our job portal and search for the Safety and PV Specialist Japanese Language role at Syneos Health.
Click the job posting to review all the details.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
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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.