Drug Safety Specialist

**Job Brief**:
Drug Safety Specialist - 12 Month FTC

**Drug Safety Specialist (Safety Operations & Alliance Management)**

**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 special situation 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 Global Drug Safety (GDS) Specialist is responsible for the day-to-day activities associated with filing safety data in the electronic TMF for all company-sponsored studies and reconciling this data with other clinical trial stakeholders.

Post Marketing commitments for authorized products, where Amicus has the responsibility for oversight of vendors, partners and affiliate compliance with applicable agreements, are part of the Alliance and Affiliate management team’s activities. The Safety Specialist will support compliance oversight of applicable vendors and affiliates by helping coordinate PV agreements, third-party PV training and maintenance of key GDS/ PV system trackers (e.g. PVAs, partner PV training, ODC programs).

**Roles and Responsibilities**:
1. Responsible for all PV vendor contracts management in ACT

2. Responsible for monthly Quality Control (QC) processes for PV/ aRMM training trackers, ICSRs data entry, regulatory submission packs

3. Supporting the Alliance Management team with the monthly post-marketing reconciliation activities

4. Supporting the Alliance Management team with the monthly PV reports including requesting, collecting, tracking of information and escalation process.

5. Maintaining the partner list and ensure they are in alignment with the information in ACT and PV training tracker

6. Support GDS with collating metrics for the quarterly quality committee meetings & other governance forums, as required.

7. Support with local literature search strategy management and tracking

8. Support with authoring and maintenance the PV/aRMM training slide decks; supporting delivery and tracking of partner & vendor PV training

9. Assist with the implementation and update of clinical trials document management system within the electronic Trial Master File (eTMF).

10. Support with maintenance of relevant PSMF annexes

11. Communicate any changes in vendor contact details with Alliance Management team and ensure the update is reflected in all impacted areas (e.g. partner list, PV training tracker, monthly PV tracker and PSMF).

12. Support EU QPPV with oversight of organised data collection (ODC) programmes (MRP, PSP etc.)

13. Support PV Quality Systems Manager with oversight of Affiliate and Vendor deviations and CAPAs

14. Responsible for daily support of eTMF activities, including set-up and management of TMF system administration and overall system maintenance for drug safety related documents

15. Ensure that clinical trial documentation is consistent with the study eTMF specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agency requirements. Ensure eTMF documentation is inspection ready

16. Upload SUSARs submission packs including alert letters, DSUR, 6 monthly line listings into TMF

17. Upload SMT meeting minutes and PV vendor SAE listings into TMF.

18. Amicus contact person with CT vendors (e.g. CRO, PV vendor) to manage PV documents transfer from their TMF to Amicus eTMF according to the study specific tracker.

19. Update central submission trackers with data from individual Contract Research Organization (CRO) trackers and upload into TMF.

20. Support with reviewing clinical trials and post marketing related plans (e.g. safety management plans and data management plans)

21. Supporting ad hoc administrative tasks and quality checks of GxP documents and assigned projects, as required

**Educational Requirements**:

- Undergraduate study in life-sciences or natural sciences preferred.

**Professional Work Experience Requirements**:

- Demonstrable experience in PV operations

**Experience and Skills**:

- Good organizational skills
- Excellent verbal and written skills and can deal effectively with all levels of management.
- Proficient in 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 Behaviours
- Passion for rare disease and patient focused.

**Travel**
- No routine travel required (exceptional travel may be required to support PV inspections, audits or other GDS