Patient Safety & Pharmacovigilance Officer

  • Job Reference: C220916F4
  • Date Posted: 16 September 2022
  • Recruiter: Pharmaxo
  • Website: https://careers.qphl.co/
  • Location: Corsham, Wiltshire, England
  • Salary: £25,000 to £30,000
  • Bonus/Benefits: Bens
  • Sector: Healthcare & Medical
  • Job Type: Permanent
  • Work Hours: Full Time

Job Description

Patient Safety & Pharmacovigilance Officer

Commit to excellence.  Join our team “Where patients come first”.

About us

Pharmaxo Pharmacy Services Limited is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.

The compounded drugs used in its drug services are provided by its sister company Qualasept Ltd t/a Bath ASU, which also produces over 3,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic illness or in need of pain relief.

We are looking for someone that is passionate about making a difference to patient lives, dedicated to improving company processes, has a drive to be an expert in what they do, wants to be part of our fantastic company community and is as committed to their career training and progression as we are. Do you have the qualities that we are looking for? If so, you could join our friendly and dynamic team.

Your role

You will be responsible for ensuring Pharmaxo is fully compliant with Good Pharmacovigilance Standards (GPhV) and ensuring all key performance indicators for PV activities are monitored and met. You will be responsible for developing and managing the systems and processes in relation to all patient safety incidents; including complaints and incidents, adverse drug events and all other safety data. You will be responsible for ensuring all incidents are closed and responded to within the agreed timeframes.

Your duties & responsibilities

Patient Safety Activities:

  • You will support with the management of the Quality Risk Management program to ensure patient safety risks are identified and controlled
  • You will act as the process owner for all complaints and incident management processes, ensuring SOPs are current, compliant with regulatory requirements and fit for purpose
  • You will represent the quality team at customer meetings relating to the incident management, patient safety reporting and service quality
  • You will support in the investigation of service complaints alongside the Patient Services Managers and Pharmacy Team
  • You will be the lead for root cause investigation training; to develop the root cause investigation skills of the team to ensure a focus on learning
  • You will work with Business Intelligence to develop reports on regulatory and operational Key Performance Indicators
  • You will be responsible for the timely submission of NHS and pharma Key Performance Indicators (KPI) and developing metrics and tools to demonstrate improvements in patient safety
  • You will support the Department Managers in all activities relating to regulatory inspection and external audits
  • You will be required to develop and deliver mandatory quality training for all staff, including management of complaints and incidents in line with RPS Homecare Standards
  • You will work with the Registered Manager to meet the recording, investigation and corrective requirement for Regulated Activities
  • You will create high quality verbal and written responses to informal and formal complaints
  • You are required to develop effective trending and measures for all patient safety incidents to support department managers in the improvement of processes
  • You will manage timescales applied to quality improvement actions and Corrective and Preventative Actions (CAPAs)
  • You will be responsible for periodic review of all patient safety databases as a part of quality control processes

Pharmacovigilance Activities:

  • You will be the key contact for all Pharmacovigilance (PV) training activities, including delivery of approved training
  • You will be responsible for the implementation of all PV requirements for new services including the review of Pharmacovigilance Agreements, supplier qualification audits and lead on PV elements of pharma audits.
  • You will be accountable for mandatory PV training, to ensure compliance with GPhV requirements
  • You will be required to develop a robust team who can accurately deliver PV requirements including but not limited to Source Data Verification and PV reconciliation tasks
  • You will supervise and provide oversight of the receipt, processing and forwarding of all patient safety case reports
  • You will process individual case safety reports including expedited reporting to relevant competent authorities
  • You will communicate with healthcare professionals to obtain supplementary information on serious adverse events and serious adverse reactions to the Group’s products
  • You will be accountable for Pharmaxo KPI performance for all PV activities
  • You will contribute to the preparation of accurate, high quality pharmacovigilance reports within agreed regulatory timelines to assist in meeting the Company’s development targets and excellence
  • You will be required to develop training effectiveness tools for ensuring ongoing staff compliance with PV recording and reporting requirements
  • You will support the PV activities for clinical trial activity; Provide an overview of pharmacovigilance definitions and procedures to study investigators and site monitors at study set-up, and whenever necessary during the running of the trial, to ensure that serious adverse events are reported in a timely and complete manner
  • You will provide an overview of pharmacovigilance definitions and procedures to study investigators and site monitors at study set-up, and whenever necessary during the running of the trial, to ensure that serious adverse events are reported to the Company in a timely and complete manner

The skills & attributes you will bring:

  • You will understand UK Pharmacovigilance standards in a healthcare or clinical trial setting.
  • You will be capable of data analysis and use of Excel to create reports and metrics for monitoring and measuring risks.
  • You will be able to plan and manage regulatory audit activities and be confident when dealing with regulators and customers

Benefits:

- Salary: £25,000 - £30,000

- 29 days holiday of holiday (including bank holidays)

- Pension Scheme

- Company bonus scheme

- Life Assurance

 

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