Description
Syneos Health is seeking a Safety & PV Coordinator in Dalian. As a Safety & PV Coordinator, you will be responsible for ensuring compliance with safety reporting regulations and maintaining high-quality safety data.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs)
- Assist in processing ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability
- Enter data into safety database, code events, medical history, concomitant medications, and tests
- Compile complete narrative summaries and identify information to be queried
- Assist in generating timely, consistent, and accurate reporting of expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, and maintenance of drug dictionary
- Validate and submit xEVMPD product records
- Identify and manage duplicate ICSRs
- Participate in audits as required
Qualification Requirements
- Bachelor's degree in life science, registered nurse, pharmacist, or equivalent combination of education and experience
- At least one year of experience in pharmacovigilance-related projects
- Experience handling medical devices preferred
- Working proficiency in English
- Safety database systems and knowledge of medical terminology required
- Good understanding of clinical trial process and safety reporting regulations
- Proficiency in Microsoft Office Suite and other software applications
What We Offer
- Opportunity to work with a leading life sciences services organization
- Collaborative and dynamic work environment
- Professional development and growth opportunities