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.
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 data for completeness, accuracy, and regulatory reportability
- Code events, medical history, concomitant medications, and tests
- Compile narrative summaries and identify information to be queried
- Assist in generating timely and accurate reporting of expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, and MedDRA coding
- Validate and submit xEVMPD product records
- Identify and manage duplicate ICSRs
- Participate in audits as required
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, 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
What We Offer
- Opportunity to work with a leading biopharmaceutical solutions organization
- Collaborative and dynamic work environment
- Professional development and growth opportunities