Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality 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 company-sponsored 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).
The PV Operations Technician is responsible for the day-to-day activities supporting the GDS function as per the listed roles and responsibilities. This is a 12 month Fixed Term Contract position.
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 inspection-ready.
* Upload development programme meeting minutes, and PV vendor SAE listings into the GDS SharePoint/TMF as needed.
* Support delivery and tracking of partner & vendor PV training.
* Support ad hoc administrative tasks and quality checks of GxP documents.
* Support the Alliance Management team with the monthly post-marketing reconciliation activities.
* Support the Alliance Management team with the monthly PV reports including requesting, collecting and tracking of information.
* Maintain the partner list and ensure they are in alignment with the information in ACT.
* Responsible for all PV vendors contracts management in ACT.
* Support budgetary management and vendor invoice.
* Support local literature search strategy management and tracking.
* Support data entry into the GDS tracking system.
* Support ad hoc GDS activities when requested.
Requirements
Educational Requirements
* Undergraduate study in life-sciences, natural sciences or engineering field preferred.
Professional Work Experience Requirements
* Undergraduate study in life-sciences, natural sciences or engineering field preferred.
Experience And Skills
* 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.
Other Skills/Attributes
* 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 patient-focused.
Travel
* 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.
Seniority level: Entry level
Employment type: Contract
Job function: Management and Manufacturing
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