Manager, PV Quality Projects and Metrics (Homebased in Europe)
- Guildford, UK
- Employees can work remotely
PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.
The Manager, Quality Projects and Metrics is responsible for leading PrimeVigilance’s Quality Projects and Metrics team, ensuring that compilation, analysis and reporting of quality and compliance metrics is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements.
The Manager, Quality Projects and Metrics is also responsible for ensuring the delivery of assigned quality related projects across the Quality group.
The Manager, Quality Projects and Metrics will lead all activities associated with the compilation, maintenance and management of PrimeVigilance’s Quality and Compliance Metrics. Responsibilities include, but are not limited to:
- Line management of the Quality Projects and Metrics Team
- Identifying the key areas required for monitoring Quality and Compliance throughout the operational teams and agreeing suitable KPIs with functional heads in order to generate meaningful and useful quality and compliance data.
- Maintaining oversight of the compilation, analysis and reporting of Quality and Compliance Metrics and ensuring that deliverables are provided on time.
- Maintaining all procedural documents associated with the Quality and Compliance Metrics process in QMCS.
- Review and approval of monthly Quality and Compliance Reports
- Partnering with functional heads to provide recommendations and guidance on necessary actions in order to address trends and non-compliance and ensuring that deviations have been raised as appropriate.
- Accountable for appropriate escalation of all significant quality or compliance issues to Head of Quality.
- Driving continuous improvements to the processes for monitoring Quality and Compliance throughout the Company (for example collating valuable Quality and Compliance data for reporting to the GQC on a quarterly basis).
The Manager, Quality Projects and Metrics is responsible for ensuring the delivery of their assigned projects across the quality group. Working cross functionally, the Manager, Quality Projects and Metrics will contribute to the continuous success of the Quality team in ensuring that an efficient and seamless service is delivered across the Company.
Projects will be assigned by the Head of Quality and may be related to any aspect of the Quality Cycle, including, but not limited to:
- Deviation reporting and trending
- Procedural creation, management, revision
- Support with client related quality activities
- Analysis and reporting of quality related data
- Support of Audits and Inspections
The Manager, Quality Projects and Metrics will support the PrimeVigilance Senior Leadership Team as required.
- Educated to degree standard
- Extensive experience working within Pharmacovigilance
- Significant experience in a Quality and Compliance role.
- Previous experience within a service provider environment
- First class analytical and investigative skills
- Previous experience working for a Pharmaceutical Company
- Line management experience
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company
- Excellent skills in leadership planning, organisation and communication.