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 obtaining and maintaining awareness of current and evolving Pharmacovigilance Regulatory Requirements for medicinal products at all stages of development, with particular focus on ethical unlicensed medicine access; Working within the Pharmacovigilance function delivering on all pertinent Clinigen group business goals for the services divisions in a manner that ensures compliance with all relevant legislation and meets the expectations of the clients.
The Key responsibilities for this role are:
- To act as the Subject Matter Expert for PV Regulatory Requirements.
- Monitors sources of Pharmacovigilance requirements e.g. agency websites, Cortellis etc and develop and coordinate with global network to obtain and maintain awareness of current and evolving local Pharmacovigilance Regulatory Requirements (PVRRs) for clinical, post-marketing and unlicensed medicinal product use.
- Develops and maintains relationships with local PV representatives.
- Performs or oversees change analysis and provides regular update reports on changes to PVRRs to key functions and applicable clients.
- Coordinates cross-functional impact assessment and development of implementation plan (as required).
- Monitors timely implementation of changes in PVRRs and reports on Key Performance Indicators (KPIs) and escalates any non-compliance as needed to senior management.
- Coordinates annual verification of global PVRRs.
- Coordinates internal review and commenting process during Regulatory Authority/Agency consultation periods for relevant new or updated guidance.
- Supports early-access programme set-up activities, providing expert advice for clients and healthcare professionals (as needed) in understanding local responsibilities for pharmacovigilance.
- Responsible for delivery of a PV Regulatory Intelligence service which ensures compliance with all relevant PVRRs and meets the expectations of clients.
- Develop and maintain relationships with external industry associations/forums and regulatory agencies.
- Prioritisation of activities which support the Clinigen focus on the Right Patient, Right Medicine, Right Time.
- Keep up to date with, implement and/or cascade new/changes to legislation pertaining to the regulation of medicines access in the US, EU and ROW
- Active communication with a range of national and international regulatory, policy and related bodies and institutions with regards to medicines access
- Involvement in cross functional technical and regulatory networks, both relating to pharmaceutical legislation and local GVP rules and guidance
- Attendance at relevant conferences and meetings
- Develop and maintain effective business relationships with Clinigen Group colleagues
- Participate fully in the Company’s Personal Performance and Development process
- Undertake training and development relevant to the job
The successful candidate will have the following:
- Bachelor's Degree in Biological/Life Sciences, pharmacy or medicine
- Minimum 7 years experience pharmacovigilance
- Broad experience and knowledge of Pharmacovigilance legislation
- Experience working in early access/Compassionate use area an advantage
- Cultural awareness and experience of working in a global environment
- 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
- Ability to facilitate, lead and influence effective cross-functional and global interactions and discussions.
Proven experience of working to meet high standards and provide excellent customer service
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.