Patient Safety Coordinator

2 weeks ago


Corsham, United Kingdom Qualasept Full time

**_Commit to excellence. Join our team Where patients come first._**

**Your role**:
You will be responsible for working across the Pharmaxo business to support the organisation in achieving regulatory compliance and delivering a culture with patient safety at its core.You will be a key part of the quality team performing administration tasks across a range of regulatory areas. You will be an enthusiastic, motivated individual with a keen interest in patient safety.You will be responsible for a range of processes including Pharmacovigilance, complaints, incidents and deviations reporting and documentation. You will coordinate investigations and ensure all activities are undertaken within agreed timelines. You will be required to perform administration tasks to ensure we are always compliant with our NHS and Pharma contracts for Pharmacovigilance, Patient Safety and Deviations.
**Your Duties & responsibilities**:
**Pharmacovigilance, Complaints and Incidents**:

- Proactively engage with operational staff to encourage a culture of openness, learning and transparency
- You will be responsible for the administration, triage and reporting of all Pharmacovigilance, and Safety reports
- You will ensure external reporting is completed in line with regulatory requirements
- You will coordinate the triage, investigation and responding of complaints and incidents in line with Royal Pharmaceutical Society Homecare Standards for Complaints and Incidents
- You will undertake first line investigations of all complaints, incidents, dispensing errors etc to allow in depth, accurate and clear investigations by all departments within Pharmaxo.
- Support the quality team to ensure all operational service complaints and incidents are appropriately managed, responded to and closed in line with internal and external Key Performance Indicators.
- You will ensure lessons learned following safety events are implemented into practice
- Own the process for all Product Quality Complaints that are reported into Pharmaxo
- You will be required to complete monthly source data verification and reconciliations for all Pharmacovigilance reports
- Support and provide administrative support in the completion of minutes, statement requests and meeting organisations.
- Support in Safety training activities, including delivery of Pharmaxo Pharmacovigilance training and Complaints and Incidents workshops
- You will contribute to future project planning of Patient Safety documentation and processes
- You will be process driven and identify ways of simplifying and improving reporting and training processes

**Data and Reporting**:

- Support the PV & Patient Safety Officer in the data creation for Key Performance Indicator (KPI) reporting for all patient safety activities
- You will monitor PV reporting compliance and work with teams to achieve compliance
- You will be confident in manipulating Excel data to create and monitor compliance metrics to identify trends and potential risks or patient safety concerns.
- Work with the Patient safety officer and Business Intelligence to develop reports on regulatory and operational Key Performance Indicators to present to the management team and the wider business
- You will attend external meetings as required

**Quality Coordination**
- As a part of the Quality team, you will be required to assist in administration of tasks across a range of areas, including but not limited to: CAPA Management, Change Control, Documentation, Quality Metrics, Risk Management, Audit and Inspection, Supplier Assurance, Information Governance, Data Integrity and Validation
- You will be responsible for the management of any shared quality inboxes to support and resolve internal and external quality queries.
- Assist in managing timescales actions and Corrective and Preventative Actions (CAPAs) for quality improvement
- You will contribute to the writing, review, and validation of SOPs across the organisation

**The skills & attributes you will bring**:

- You will be proactive in identifying opportunities for improvement
- You will be flexible and organised with good time management skills
- You will have administrative experience and will be competent in manipulating data within MS Excel
- Understand the regulatory and contractual agreements that we work within
- You will have an investigative mind and be able to work through processes systematically and objectively
- You will be tenacious and consistent in your approach

**Review**:
This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company and department grows.

**Salary**: £20,844.00 per year


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