Offer summary

Qualifications:

Bachelor’s Degree in life science, nursing, pharmacy, or equivalent experience., Knowledge of safety database systems and medical terminology is required., Understanding of clinical trial processes and pharmacovigilance regulations is essential., Proficiency in Microsoft Office Suite and good communication skills are necessary..

Key responsabilities:

Enter and track individual case safety reports (ICSR) in quality systems.

Process ICSRs according to Standard Operating Procedures and safety plans.

Compile narrative summaries and ensure timely reporting of expedited reports.

Maintain compliance with regulatory requirements and submit relevant documents to the Trial Master File.

Job description

该职位来源于猎聘工作时间：周一至周五15:30-0:30 主要职责：PV中英互译，Argus系统中的bookin及其他涉及业务工作地点：可全国任何城市homebase JOB SUMMARY Assists in all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.

JOB RESPONSIBILITIES

Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. o Enters data into safety database. o Codes events, medical history, concomitant medications and tests. o Compiles complete narrative summaries. o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. o Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process. QUALIFICATION REQUIREMENTS
Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
Safety Database systems and knowledge of medical terminology required
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), TeamShare (or other management/shared content/workspace) and internet.
Ability to work independently and in a team environment
Good 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

Required profile