QA Pharmacovigilance Officer

Galway

Basic Summary:

  • Ensure continued compliance to current EMA GVP Guidelines
  • Review, evaluate & collate Risk Assessments and PhV Questionnaires
  • Contribute to the development and maintenance of the Quality Pharmacovigilance (PV) system

 

Essential Duties and Responsibilities:

The functions of the Senior QA Pharmacovigilance Officer include but are not limited to:-

  • Work closely with the Qualified Person Responsible For Pharmacovigilance (QPPV) and other members of the pharmacovigilance team / service providers, to ensure timely, effective and appropriate processing and evaluation of Audit Reports
  • Review documents and reports necessary to maintain a compliant QA pharmacovigilance system
  • Contribute to the implementation of process / system improvements and updates to QA PV system
  • Liaising with and provide PV guidance & advice on QA PV topics to all key stakeholders
  • Identify, develop and roll-out opportunities for continuous improvement in the PV system
  • Work with stakeholders to ensure goals of the QA PV process are achieved
  • Prepare, maintaining and present PV Key Performance Indicators (KPI’s)
  • Review of Pharmacovigilance System Master File (PSMF) and associated annexes
  • Participate in the preparation and roll out of Quality PV policies, guidelines and procedures
  • Attend PV audits / inspections and meetings, as necessary
  • Monitor company/ co-partner compliance and liaising with management to mitigate identified risks
  • Establish key performance indicators (KPIs) to monitor the effectiveness and implementation of its PV systems and processes, including areas of delegation to third-party service providers and business partners.
  • Manage timelines for responses to PV queries from all stakeholders and customers
  • Supporting all PV outsourced activities
  • Manage & oversee PV variation changes and updates, transfer of PV information to other internal departments, PV SOP’s and PV training
  • Participate with inter-departments PV discussions as required
  • Other ad-hoc duties as requested by Management

 

 

Person Specification:

·         3rd level degree in a relevant scientific or PV related discipline.

  • Minimum 3 years in a PV environment
  • Ability to work on multiple projects simultaneously, while maintaining excellent oral, written and presentation / communication skills.
  • Experience in busy problem solving environment with the ability to work to tight deadlines Excellent PV knowledge for generic products, processes and worldwide PV guidelines.
  • Highly motivated person, with the ability to manage deadlines, work effectively as part of a multi-disciplinary team and ability to work unsupervised and on own initiative

·         Good IT skills and computer

QA Pharmacovigilance Officer

Galway