Description
Syneos Health is seeking a Safety & PV Specialist I to work remotely in China.
The successful candidate will be responsible for ensuring compliance with safety and pharmacovigilance regulations, processing Individual Case Safety Reports (ICSRs), and maintaining safety tracking for assigned activities.
Key responsibilities include:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-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 the generation of 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
The ideal candidate will have:
- Bachelor's degree in life science, registered nurse, pharmacist, or equivalent combination of education and experience
- Knowledge of safety database systems and medical terminology
- Understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements
- Proficiency in Microsoft Office Suite, Visio, email, and internet
- Excellent communication and interpersonal skills
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards program.