Description
Syneos Health is seeking a Safety & PV Specialist I to join their team in Wuhan.
As a Safety & PV Specialist I, you will be responsible for ensuring the safety of patients and products throughout the clinical development process.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs)
- 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
- Apply safety reporting regulatory intelligence to all safety reporting activities
Qualifications
- 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
- Ability to work independently and in a team environment
- Excellent communication and interpersonal skills
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Benefits
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.