Careers
To apply for an advertised position please send your CV together with a covering letter or email stating your salary expectations to the person indicated. For all recruitment enquiries please contact Crissy Clark on 01980 557009, or e-mail ca@gwpharm.com. Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.
Pharmacovigilance Associate
GW Pharmaceuticals plc is listed on AiM and is licensed by the Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio of cannabinoid prescription medicines including Sativex®, to meet patient needs in a wide range of therapeutic indications.
Term
GW is now looking to recruit a full-time permanent staff member to the Pharmacovigilance team which will be based at GW’s new offices in Histon, Cambridge.
Primary Duties
Working in our global Pharmacovigilance Department the candidate will gain exposure to many different aspects of Pharmacovigilance. Following induction to the company and training, the Pharmacovigilance Associate would be responsible for:
• Case processing including data entry, review and assessment of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources onto our global safety database (ARISg), in accordance with company SOPs and regulatory requirements
• Assisting with SAE reconciliation.
• MedDRA coding.
• Literature review.
• Using and maintaining the global safety database.
• Contributing to the ongoing enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
• Supporting the Pharmacovigilance team with the creation and quality control of safety reports in CSRs, DSUR/PSURs, and regulatory dossiers.
Key attributes/Skills/Education
The candidate will ideally be a life sciences graduate or have relevant scientific work experience.
Competent with medical terminology, excellent communication abilities and possess good IT skills. Previous use of a safety database (preferably ARISg web based) is required. A high standard of organisation, narrative writing and impeccable attention to detail is essential.
This is an excellent opportunity for a candidate seeking to broaden their safety knowledge in both a clinical trial and post-marketing setting and to be part of a progressive department.
Clinical QA Manager
An excellent opportunity has arisen to work in one of the most exciting areas of modern medicine within GW Pharma Ltd, an innovative pharmaceutical company, which is at a key point in its development with large scale global Phase III oncology studies running.
We are seeking a Clinical QA Manager to manage the GCP CQA group concentrating on these Phase III studies leading to US FDA NDA approval, but also covering exploratory Phase I and II studies for the products in GW’s research pipeline. As a key manager within the multi-disciplined company QA team you will utilise your extensive GCP knowledge and excellent leadership and communication skills to lead the CQA audit team and oversee the design and implementation of the audit programme for GW’s clinical development function, including internal systems, external suppliers, documentation and international investigator site audits.
You will also provide support, advice, education and training to other departments involved in GW’s clinical trials and may become involved with cross-functional GMP and GLP audits. As part of the role, you will be tasked with organising a quality system for introducing assessments for training competency at all operational levels.
As well as having extensive knowledge of clinical trials safety reporting requirements, you will also have experience of the commercial commitments for Pharmacovigilance for both EU and US, in order to manage quality audits for these systems in Phase IV studies and a worldwide marketplace.
You will host Regulatory Authority GCP and Pharmacovigilance inspections where required and manage the CAPA process to close out. You will give strong input into the set up and maintenance of procedures within Clinical Development departments and support the development and audit of licence application dossiers.
This will be a broad based position, providing exposure to all aspects of drug development. Reporting to the GW Director of Quality and based at the company’s Clinical Development offices in Histon, Cambridgeshire, this is a highly interactive and influential role, requiring self-reliance, effective strategic thinking and planning skills, the ability to network, lead a busy but well-established and confident team, and build successful interfaces both internally and externally. Excellent leadership, negotiation and influencing skills are absolutely essential.
Qualifications/experience required:
• Ideally a bioscience degree or nursing qualification
• Broad experience in clinical research and commercial pharmacovigilance
• Must have worked in a GCP or regulatory environment for at least eight years
• Three to five years’ quality assurance experience in a GXP environment
• A working knowledge of Oncology or Neuroscience would be advantageous
• Experience of successfully managing a team
• A full driving licence is required along with the ability to travel approximately 25% both within the UK and overseas
If you have the skills and drive to succeed in a dynamic and fast paced environment, we can offer competitive remuneration and career potential.
QA Laboratory Manager
A QC Laboratory Manager is required to lead and manage a team of 7 analysts in a small but fast-growing pharmaceutical company.
The QC Department supports the Production departments, stability studies, and provides additional support for the Development departments and quality investigations.
Ideal candidates will have a BSc in Chemistry (or equivalent) and have experience in managing or supervising an analytical laboratory in a GMP environment encompassing Pharmacopoeial and in-house testing. Experience in stability, method validation and troubleshooting for various analytical techniques such as HPLC, GC, IR, and UV is essential. Empower experience would be beneficial.
The laboratory is responsible for the analysis of pharmaceutical raw materials, active ingredients, and finished products to ensure that they comply with internal and regulatory specifications. Chemical analysis, stability testing, protocol writing, and checking analytical data in accordance with cGMP are all within the scope of the role.
Key duties and responsibilities will include:
- Providing leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development.
- Improving the overall department productivity and efficiency
- Ensuring all QC operations are carried out in accordance to cGMP
- Reviewing and approving analytical data & results, ensuring that they comply with internal and regulatory specifications
- Ensuring robust training and self-inspection programs within the laboratories, as well as the review of SOPs, investigations, specifications, methods, validation reports, and cleaning verification reports
- Implementing new procedures
- Maintain the risk-based and scientific-based quality system as part of the Quality Unit
- Establishing and maintaining efficient workflows to ensure operational excellence
- Facilitation of method transfers
Applications from Qualified Persons are welcomed in order to provide on-site coverage to the main company QP.
All applications to be received by Friday 13th January 2012.
GCP Quality Assurance Administrator
An excellent opportunity has arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. Based in our new offices in Histon, Cambridge, the administrator to the multi-disciplined company QA team would have an ordered mind and organised approach to provide administrative support for the team, who have a heavy schedule of audits for 2012 and beyond. The role will include the following duties:
• Providing support to the CQA team, such as scheduling and organising audits with the associated administration
• Updating and managing the corrective and preventative actions database arising from audits and inspections
• Managing key aspects of SOP administration for the site
• Setting up meetings and calendar appointments
• Taking and distributing minutes as required
• Supplying Departmental metrics in support of Quality Review meetings
• Responding to email and telephone queries
• Supporting the company archivist in his role of archive management
• Assisting with internal documentation / administration audits and related filing and organisation
• Supporting training and reference material activities provided by CQA
• Other CQA administration tasks
Together with excellent organisational skills and an eye for detail, patience, the ability to finish tasks and determination are also useful attributes, together with good communication and people management skills. Computer literacy in MS Office packages and Adobe Acrobat is required. A knowledge and understanding of Pharmaceutical Good Clinical and/or Pharmacovigilance Practice or of Quality Systems in the pharmaceutical industry would be an advantage.
Reporting to the Clinical QA Manager, this is an interactive role, requiring a degree of self-reliance, effective planning skills, the ability to communicate and operate within a busy team, and build relationships both internally and externally.
Qualifications/experience required:
• Educated to A-Level
• Experience of Quality Assurance
• Computer literate in Microsoft packages
• Strong communication skills both written and oral
• Excellent time management and organisational skills
This is a full time permanent position. If you believe that you have the skills and drive to succeed in this role, we can offer competitive remuneration and benefits.
To apply please send your CV and covering letter to:
Crissy Clark
GW Pharma Ltd
Building 114
Porton Down Science Park
Salisbury
Wiltshire
SP4 0JQ
or by email to: