Sr Associate, PV Quality Systems

Job Brief

Sr Associate, PV Quality Systems (Marlow, UK or Dublin, Ireland)

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

The Snr. PV Quality Systems Associate is responsible for supporting the Assoc. Director, PV Quality Systems in relation to document management and incoming quality and compliance data such as Standard Operating Procedures (SOPs), Deviation and CAPA management and PV Change Controls. The Snr. PV Quality Systems Associate is a member of the PV Operations team ensuring the accurate distribution and co-ordination of information and reports for PV quality and compliance activities.

Roles And Responsibilities

• Manage all aspects of QPPV mailbox, including but not limited to:
• Monitoring and triage of the QPPV mailbox;
• Receipt, tracking and triage of Vendor deviations;
• Coordination of QPPV and Affiliate PV oversight meetings and supporting content creation.
• Coordination the Amicus PSMF updates:
• Support Affiliate PV representatives with the preparation of any local PSMF/ PV System; Sub-file requirements ensuring alignment with the global PSMF.
• Support GDS colleagues with PV QMS activities including deviation and CAPA management and Change Controls.
• Compliance metrics collation reporting:
• Generation of PV system quality metrics.
• Assist with preparation of periodic monitoring of metrics/ KPIs (e.g. PV System Performance Report, PV Quality Management Review).
• Support PV Alliance Management operations: Local Medical Literature Monitoring (MLM) oversight and tracking (weekly/monthly) and coordination of the periodic review of local MLM search strategies (annual).
• PV-SOP management (includes Affiliate QMS documents managed by GDS): Partner with GDS and Quality Assurance colleagues to coordinate periodic review/ update of GDS/ Affiliate pharmacovigilance procedural documents and templates.
• MasterControl ‘super-user’ for GDS: Support GDS Subject Matter Experts (SME) with Master Control operations and procedural update training.
• TrackWise ‘super-user’ for GDS: pull necessary metrics for periodic review at PV operational review meetings (e.g. deviations and CAPAs, change controls).
• Support maintenance of all GDS MasterControl job codes and assist with coordinating the periodic GDS Curriculum Review.
• Monitor and track emerging PV regulatory intelligence and coordinate the GDS leadership/ functional SMEs impact assessment on the Amicus PV system including via Change Control, where required;
• Support inspection readiness activities and provide operational support during internal process audits/ external regulatory inspections.
  
  

Requirements

Educational Requirements

• Bachelors degree in a biomedical science or healthcare-related field, such as, pharmacy or nursing
  
  

Professional Work Experience Requirements

• 2-3 years’ experience in Pharmacovigilance - experience of working with or within a PV Quality Management function is desirable
• Knowledge of EU GVP/GCP legislation and regulations
• Experience with GVP inspections/ audits and CAPA management desirable
• Experienced in working in global matrix teams
  
  

Experience And Skills

• Experience must include a proven understanding of pharmacovigilance principles and operational experience of working in a pharmaceutical PV function
• Excellent verbal and written communication skills, including formal presentations
• Proficiency in Microsoft Excel, PowerPoint and Word required
• Sound organizational skills with the ability to prioritize tasks as required
• Able to take full accountability for assigned tasks
• Excellent interpersonal, team working skills required
  
  

Other Skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused
  
  

Travel

Minimal travel expected (5% time) to attend company/ project meetings and professional development courses.

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.