Safety & PV Specialist/药物警戒专员社

面议

市辖区1年及以上

发布时间：2023-09-06

职位描述

JOB SUMMARY


Performs 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. Ensures that the project/program activities are completed in accordance with agreed timelines, allocated budgets and required quality standards. Responsible for providing delivery and expertise with minimal oversight. Coordinates workflow to ensure delivery of project/program. Accountable to the Project Lead or Safety Program Delivery Manager at the project/program level and line manager for deliverables. May act as a mentor for less experienced associates. At a project level, may act as Safety Program Delivery Lead for local or regional studies.




JOB RESPONSIBILITIES

Coordinating workflow to ensure delivery of project.Escalates issues with project deliverables, finance and quality to Safety Program Delivery Lead/Manager or Line Manager as appropriate in a timely mannerHas an understanding of financial measures, work orders, performance metrics (including quality parameters, monthly budget reports, and changes in scope) and project budgets. Prepares Safety Management Plan.Assists in the preparation and participates in internal project review meetings as required.May enter information into PVG quality and tracking systems for receipt and tracking ICSR.May process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans.Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.Enters data into safety database.Codes events, medical history, concomitant medications and tests.Compiles complete narrative summaries.Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databasesEnsures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.Provides training of Investigators on ICSR reportingParticipate in audits/inspections as requiredEnsures 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 requiredIn depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and PharmacovigilanceProficiency 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 environmentStrong communication, presentation, interpersonal skills, both written and spokenStrong organizational skills with proven ability to prioritize and work on multiple tasks and projectsDetail oriented with a high degree of accuracy and ability to meet deadlinesAble to make effective decisionsMinimal travel may be required (up to *****************************

其他要求

招聘人数：1人
职能类别：其他运营推广职位

公司介绍