Safety and PV Coordinator - Clinical trial case processing
Safety and PV Coordinator - Clinical trial case processing
Syneos Health
Job description
Syneos Health is hiring a Safety and PV Coordinator for clinical trial case processing in Gurugram, offering a great career opportunity for life science, nursing and pharmacy graduates with 1 or more years of experience.
Company Description
Syneos Health is a leading, fully integrated life sciences services organization built to speed up customer success. It partners with innovators across drug development and commercialization, helping them handle complexity, expect change, and move faster. Its Clinical Solutions team members bring a drug development mindset and great skills to each project. About 25000 colleagues work together as problem solvers who are driven to deliver.
Job Summary
This is a full-time, office-based role for a Safety and PV Coordinator in clinical trial case processing, based in Gurugram. The person will process Individual Case Safety Reports, review adverse event data and keep safety tracking records in order. The role also supports regulatory reporting and safety documents for clinical trials. Candidates need at least 1 year of clinical trial case processing experience.
Key Responsibilities
Enter and track Individual Case Safety Reports, called ICSRs, in safety and tracking systems.
Process each ICSR according to the operating procedures and the project safety plans.
Check the adverse event data to make sure it is complete and correct.
Update the safety tracking records for the work that I'm responsible for.
Assist in preparing and sending safety reports to the regulators and the clients on time.
Ensure the correct documents are placed in the Trial Master File and the Pharmacovigilance System Master File.
Follow the rules for data privacy, Good Clinical Practice, Good Vigilance Practice, and all global safety regulations.
Collaborate with the project team to reach the quality goals and meet the deadlines.
Educational Qualification
A bachelor's degree in life sciences, nursing, or pharmacy is needed, or an equivalent mix of education and experience.
Candidates should have at least 1 year of experience in clinical trial case processing.
Skills Required
Experience in ICSR processing and adverse event case handling.
Understanding of clinical trials across Phases II to IV and post-marketing safety needs.
Familiarity with safety databases, such as Oracle Argus or ArisG.
Good knowledge of medical terms.
Knowledge of ICH GCP, GVP, and pharmacovigilance rules.
Attention to detail and ability to meet deadlines.
Good use of Microsoft Office.
Clear communication and teamwork.
Salary Structure
The estimated salary for a Safety and Pharmacovigilance (PV) Coordinator handling clinical trial case processing in Gurugram typically ranges from ₹4.5 Lakhs to ₹6.5 Lakhs per year.
Career Development
This role builds strong skills in clinical trial safety case processing at a global clinical research company. It can help you grow into a safety and PV specialist, senior coordinator, or wider pharmacovigilance roles over time.
How to Apply
Visit our job portal and search for the Safety and PV Coordinator Clinical Trial Case Processing role in Gurugram.
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.