Safety & PV Specialist I – Mandarin/Chinese Speaker

This is a fully remote position, open to applicants in United States.

📋 Description

• Input data into PVG quality and tracking systems for the receipt and monitoring of ICSRs as necessary.

• Aids in processing ICSRs in line with Standard Operating Procedures (SOPs) and specific project/program safety plans as needed.

• Sorts ICSRs and assesses ICSR data for completeness, accuracy, and compliance with regulatory reporting requirements.

• Inputs data into the safety database.

• Assigns codes to events, medical histories, concomitant medications, and tests.

• Compiles comprehensive narrative summaries.

• Identifies information that requires clarification and follows up until the necessary information is obtained and queries are satisfactorily settled.

• Assists in producing timely, consistent, and precise expedited reports in accordance with relevant regulatory obligations.

• Maintains safety tracking for designated activities.

• Conducts literature screening and review for safety, along with drug coding and upkeep of the drug dictionary, MedDRA coding as required.

• Validates and submits xEVMPD product records, ensuring accurate coding of indication terms using MedDRA.

• Manually recodes any un-coded product and substance terms that arise from ICSRs.

• Identifies and manages duplicate ICSRs.

• Engages in activities related to SPOR / IDMP.

• Performs quality reviews of ICSRs.

• Ensures that all pertinent documents are submitted to the Trial Master File (TMF) following company SOP/Sponsor requirements for clinical trials, as well as the Pharmacovigilance System Master File for post-marketing programs as appropriate.

• Maintains knowledge and adherence to SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.

• Cultivates constructive and professional relationships with all project team members, both internal and external.

• Participates in audits as necessary or appropriate.

• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a comparable combination of education and experience.

• Previous experience in Pharmacovigilance/Drug Safety is advantageous.

• Proficiency in Mandarin/Chinese: HSK 4 minimum; HSK 5+ preferred.

• Familiarity 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.

• Capable of working independently as well as collaboratively in a team environment.

• Exceptional communication, interpersonal, and organizational skills.

• Detail-oriented with a high level of accuracy and the ability to meet deadlines.

🏝️ Benefits

• Career development and progression opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a comprehensive rewards program.