PV Operations Technician
PV Operations Technician
Posted on :
03-03-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: PV Operations Technician (12 Months Fixed Term Contract)
Job Location: Marlow SL7 UK
Job Location Type: Hybrid
Job Contract Type: Contract
Job Seniority Level: Entry level
Amicus Therapeutics is a global patientdedicated biotechnology company focused on discovering developing and delivering highquality medicines for people living with rare metabolic diseases.
Position Summary
Global Drug Safety (GDS) is the function within Amicus responsible for the collection analysis and reporting of adverse event and drug safety data from both companysponsored clinical trials and commercial product use. Good document practice is a key aspect of clinical trial conduct and compliance. As part of this Amicus is required to record and file certain safety data in trial specific Trial Master Files (TMF).
Post Marketing commitments for marketed products where Amicus has the responsibility for oversight of vendors and affiliate compliance with the applicable agreements are part of the alliance and affiliate management activities.
The PV Operations Technician is responsible for the daytoday activities supporting the GDS function as per the listed roles and responsibilities.
Roles And Responsibilities
Educational Requirements
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job without regard to race color sex religion national origin age disability sexual orientation gender identity protected veteran disability status or any other characteristics protected by applicable federal state or local law.
Position Summary
Global Drug Safety (GDS) is the function within Amicus responsible for the collection analysis and reporting of adverse event and drug safety data from both companysponsored clinical trials and commercial product use. Good document practice is a key aspect of clinical trial conduct and compliance. As part of this Amicus is required to record and file certain safety data in trial specific Trial Master Files (TMF).
Post Marketing commitments for marketed products where Amicus has the responsibility for oversight of vendors and affiliate compliance with the applicable agreements are part of the alliance and affiliate management activities.
The PV Operations Technician is responsible for the daytoday activities supporting the GDS function as per the listed roles and responsibilities.
Roles And Responsibilities
- Assist with the implementation and update of clinical trials document management system within the electronic Trial Master File (eTMF).
- Work Closely with Global Drug Safety (GDS) Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements and completion of the monthly compliance reports
- Ensure that clinical trial documentation is consistent with the study eTMF specifications applicable SOPs ICH/GCP guidelines and other regulatory agency requirements. Ensure eTMF safety documentation is inspectionready
- Upload development programme meeting minutes and PV vendor SAE listings into the GDS SharePoint/TMF as needed
- Supporting delivery and tracking of partner & vendor PV training
- Supporting ad hoc administrative tasks and quality checks of GxP documents
- Supporting the Alliance Management team with the monthly postmarketing reconciliation activities
- Supporting the Alliance Management team with the monthly PV reports including requesting collecting and tracking of information
- Maintaining the partner list and ensure they are in alignment with the information in ACT
- Responsible for all PV vendors contracts management in ACT
- Support with budgetary management and vendor invoice.
- Support with local literature search strategy management and tracking
- Support of data entry into the GDS tracking system
- Support with ad hoc GDS activities when requested
Educational Requirements
- Undergraduate study in lifesciences natural sciences or engineering field preferred
- Undergraduate study in lifesciences natural sciences or engineering field preferred
- Good organizational skills
- Excellent verbal and written skills and can deal effectively with all levels of management
- IT Proficient including competency with validated systems Microsoft Word Excel PowerPoint SharePoint
- Good team player
- Detail oriented
- Intellectual curiosity and eager to learn about the pharmaceutical industry and clinical research
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patientfocused
- Not required
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job without regard to race color sex religion national origin age disability sexual orientation gender identity protected veteran disability status or any other characteristics protected by applicable federal state or local law.
/jobs/view/0695686c52c9b8dc7b11685f7e3b69c8
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
