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).
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 day-to-day activities supporting the GDS function as per the listed roles and responsibilities.
Roles and Responsibilities:
1. Assist with the implementation and update of clinical trials document management system within the electronic Trial Master File (eTMF).
2. 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.
3. 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.
4. Upload development programme meeting minutes, and PV vendor SAE listings into the GDS SharePoint/TMF as needed.
5. Support delivery and tracking of partner & vendor PV training.
6. Support ad hoc administrative tasks and quality checks of GxP documents.
7. Support the Alliance Management team with the monthly post-marketing reconciliation activities.
8. Support the Alliance Management team with the monthly PV reports including requesting, collecting and tracking of information.
9. Maintain the partner list and ensure they are in alignment with the information in ACT.
10. Responsible for all PV vendors contracts management in ACT.
11. Support with budgetary management and vendor invoice.
12. Support with local literature search strategy management and tracking.
13. Support of data entry into the GDS tracking system.
14. Support with 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
1. Good organizational skills.
2. Excellent verbal and written skills and can deal effectively with all levels of management.
3. IT proficient including competency with validated systems, Microsoft Word, Excel, PowerPoint, SharePoint.
4. Good team player.
5. Detail oriented.
Other skills/Attributes
1. Intellectual curiosity and eager to learn about the pharmaceutical industry and clinical research.
2. Demonstrated alignment with Amicus Mission Focus Behaviors.
3. Passion for rare disease and patient-focused.
Travel
Not required.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
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.
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