Senior Drug Safety Specialist (Safety Operations & Alliance Management) – 12-month fixed-term contract

Marlow, England, United Kingdom

6/17/2025

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 Senior 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. In addition, manage study specific Safety Management Plans (SMPs), monitor compliance with CROs, maintaining clinical partner lists.

Post Marketing commitments for authorised 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 Senior 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

• Responsible for all PV vendor contracts management in ACT
• Responsible for monthly Quality Control (QC) processes for PV/ aRMM training trackers, ICSRs data entry, regulatory submission packs
• Supporting the Alliance Management team with the monthly post-marketing reconciliation activities
• Supporting the Alliance Management team with the monthly PV reports including requesting, collecting, tracking of information and escalation process
• Maintaining the partner list and ensure they are in alignment with the information in ACT and PV training tracker
• Support GDS with collating metrics for the quarterly quality committee meetings & other governance forums, as required
• Support with local literature search strategy management and tracking
• Support with authoring and maintenance the PV/aRMM training slide decks; supporting delivery and tracking of partner & vendor PV training
• Assist with the implementation and update of clinical trials document management system within the electronic Trial Master File (eTMF).
• Support with maintenance of relevant PSMF annexes
• 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 (both clinical and post-marketing), PV training tracker, monthly PV tracker and PSMF).
• Support EU QPPV with oversight of organised data collection (ODC) programmes (MRP, PSP etc.)
• Support PV Quality Systems Manager with oversight of Affiliate and Vendor deviations and CAPAs
• 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
• 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
• Upload SUSARs submission packs including alert letters, DSUR, 6 monthly line listings into TMF
• Upload SMT meeting minutes and PV vendor SAE listings into TMF.
• Amicus contact person with CT vendors (e.g. CRO, PV vendor) for all study related queries
• Update central submission trackers with data from individual Contract Research Organization (CRO) trackers and upload into TMF.
• Support with reviewing clinical trials and post-marketing related plans (e.g. safety management plans and data management plans)
• Supporting ad hoc administrative tasks and quality checks of GxP documents and assigned projects, as required
  
  

Requirements

Educational Requirements

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

Professional Work Experience Requirements

• 2 years’ experience in PV or clinical 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 Behaviors
• Passion for rare disease and patient focused.
  
  

Travel/Location

• No routine travel required (exceptional travel may be required to support PV inspections, audits or other GDS initiatives)
• This role is a hybrid role (Tues, Wed, Thurs in office)
  
  

We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.



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.