Safety & PV Specialist - 工作时间（周一至周五15:00-0:00）

工作时间：周一至周五15:00-0:00
工作地点：可全国任何城市homebase

职位一：主要负责Book in & 翻译(中译英），要求：2年以上PV经验，医药学相关专业，良好的英文能力，有Argus系统经验，Bookin经验，EDC RAVE 系统经验更加
职位二：主要负责翻译(英译中)，要求：1年以上PV经验，有翻译相关经验，良好的英文能力

合同期限：18个月

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