Quality Assurance Specialist, Pharmacovigilance

1 week ago

Marlow, United Kingdom Lifelancer Full time

About the Job

We are seeking a Quality Assurance Specialist to join our Pharmacovigilance team in Marlow, UK or Dublin, Ireland. The successful candidate will be responsible for supporting the Associate Director, PV Quality Systems in relation to document management and incoming quality and compliance data.

Job Summary

The Senior 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. Key responsibilities include:

  • Managing all aspects of QPPV mailbox, including monitoring and triage of the QPPV mailbox; receipt, tracking and triage of Vendor deviations;
  • Coordinating QPPV and Affiliate PV oversight meetings and supporting content creation;
  • Coordinating Amicus PSMF updates;
  • Supporting Affiliate PV representatives with the preparation of any local PSMF/PV System; Sub-file requirements ensuring alignment with the global PSMF;
  • Supporting GDS colleagues with PV QMS activities including deviation and CAPA management and Change Controls;
  • Collation of compliance metrics and reporting;
  • Generation of PV system quality metrics;
  • Assisting with the preparation of periodic monitoring of metrics/KPIs (e.g. PV System Performance Report, PV Quality Management Review);
  • Supporting 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): Partnering with GDS and Quality Assurance colleagues to coordinate periodic review/update of GDS/Affiliate pharmacovigilance procedural documents and templates;
  • MasterControl 'super-user' for GDS: Supporting GDS Subject Matter Experts (SME) with Master Control operations and procedural update training;
  • TrackWise 'super-user' for GDS: pulling necessary metrics for periodic review at PV operational review meetings (e.g. deviations and CAPAs, change controls);
  • Supporting maintenance of all GDS MasterControl job codes and assisting with coordinating the periodic GDS Curriculum Review;
  • Monitoring and tracking emerging PV regulatory intelligence and coordinating the GDS leadership/functional SMEs impact assessment on the Amicus PV system including via Change Control, where required;
  • Supporting inspection readiness activities and providing operational support during internal process audits/external regulatory inspections.

Requirements

To be considered for this role, you will need:

  • A Bachelor's degree in a biomedical science or healthcare-related field, such as pharmacy or nursing;
  • 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;
  • Experience in working in global matrix teams.

Skills and Qualifications

You will need to demonstrate:

  • 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;
  • Sound organisational skills with the ability to prioritise tasks as required;
  • Able to take full accountability for assigned tasks;
  • Excellent interpersonal, team working skills.

Salary and Benefits

We offer a competitive salary of approximately £40,000 per annum, depending on experience. In addition, you will receive a range of benefits including minimal travel expected (5% time) to attend company/project meetings and professional development courses.

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