Description
Syneos Health is seeking a Safety & PV Specialist I to join their team in Dalian.
The successful candidate will be responsible for ensuring the timely and accurate reporting of safety information related to clinical trials and post-marketing programs.
Key responsibilities include:
- 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
- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved
- Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
- 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
- Manually recode un-recoded product and substance terms arising from ICSRs
- Identify and manage duplicate ICSRs
- Participate in activities related to SPOR / IDMP
- Conduct quality review of ICSRs
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements
- Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process
- Foster constructive and professional working relationships with all project team members, internal and external
- Participate in audits as required
- Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
The ideal candidate will have:
- Bachelor's degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Knowledge of safety database systems and medical terminology
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
- Ability to work independently and in a team environment
- Excellent communication and interpersonal skills, both written and spoken
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail-oriented with a high degree of accuracy and ability to meet deadlines