Sr Associate, PV Quality Systems

Amicus Therapeutics

Marlow, United Kingdom

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

Bachelor's 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.