Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The Group consists of five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our group of complementary businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle. Through five businesses, Clinigen Clinical Trial Services, Idis Managed Access, Idis Global Access, Link Healthcare and Clinigen Specialty Pharmaceuticals, we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. We are currently 500+ people, headquartered in Burton-on-Trent in the UK, with offices in London, Weybridge, Surrey, the US, Australia, China, Japan, South Africa and Singapore. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while physicians and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.
The role is responsible for the monitoring and reporting on PV compliance with contractual obligations, procedural documents and relevant Pharmacovigilance legislation. Ensuring readiness and supporting the team through any PV audits and inspections. Responsible for driving a culture of continuous improvement, reviewing procedural documents and developing, maintaining and delivering training for PV staff.
The Key responsibilities for this role are:
- Regularly monitors compliance with contractual obligations, procedural documents and relevant pharmacovigilance legislation through collation of PV Key Performance Indicators (KPIs).
- Chairs the PV Quality & Compliance meeting and provides regular metrics reports and escalation of any significant non-compliance to the Head of PV.
- Producing compliance metrics reports for internal use and for provision to clients where required.
- Responsible for the late safety report investigation process, performing trend analysis, and assessing CAPA effectiveness.
- Regularly tracks CAPA deliverables, timely investigation and responses to deviations and service-complaints.
- Provides support and guidance to the team when performing root cause analysis for any deviation and reviews all deviations, service complaints and CAPAs before logging with Quality department.
- Collaborates with Quality department to ensure the completion of annual pharmacovigilance partner risk assessments and audit plans.
- Assists with the preparation, facilitation and follow-up of PV audits and regulatory authority inspections
- Provides back-room support through all PV audits/inspections and performing QC of all documents requested
- Evaluating procedural documents needed to comply with contractual obligations and regulatory requirements & developing process efficiencies and ensuring continuous improvement.
- Provision of guidance and training to PV staff, developing standard training modules
- Prioritisation of activities which support the Clinigen focus on the Right Patient, Right Medicine, Right Time.
The successful candidate will have the following:
- Bachelor's Degree in Biological/Life Sciences, pharmacy or medicine
- Minimum 7 years experience pharmacovigilance, with some experience working in a compliance role.
- Broad experience and knowledge of Pharmacovigilance legislation
- Experience working in early access/Compassionate use area an advantage
- Ability to build relationships with key internal and external customers
- Proven experience of working to meet high standards and provide excellent customer service
- Excellent attention to detail and ability to work under pressure
- Extensive knowledge of MS Office Applications and systems
- Proven results and solutions-orientated
- Excellent organisational and project management skills
- Outstanding written, verbal and interpersonal communication skills
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
If this role is of interest to you please send a recent copy of your CV to firstname.lastname@example.org and a member of the Resourcing team will be in touch.