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
- 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
- Foster constructive and professional working relationships with project team members
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 and internet
- Excellent communication and interpersonal skills
- Ability to work independently and in a team environment
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards program.