Description
Syneos Health is seeking a Safety & PV Specialist I - Mandarin/Chinese Speaker. The successful candidate will be responsible for ensuring the quality and timeliness of safety reporting, maintaining safety tracking for assigned activities, and performing literature screening and review for safety.
Job Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory report ability
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
- Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA
- Identify and manage duplicate ICSRs
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements
- Foster constructive and professional working relationships with all project team members, internal and external
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience
- Prior experience in Pharmacovigilance/Drug Safety is a plus
- Mandarin/Chinese proficiency: HSK 4 minimum; HSK 5+ preferred
- Experience with Safety Database systems and knowledge of medical terminology
- Understanding of clinical trial processes (Phases II–IV) and/or post-marketing safety requirements, including ICH GCP, GVP, and related regulations
- Proficient in MS Office (Word, Excel, PowerPoint), Visio, Outlook, Team Share, and internet tools
Shift Timings:
- Tuesday to Saturday, 3 PM – 12 AM (night)
- Flexibility may be required based on business needs; shift extensions may be necessary