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.
Regulatory Affairs – Maternity cover
A Regulatory Affairs Specialist with Regulatory work experience is sought to join a Regulatory Affairs team at GW Pharma Ltd’s HQ on the Porton Down Science Park on the Hampshire/Wiltshire border. The job will be for up to one year’s maternity cover.
GW is one of the most successful of the UK Biotech companies and is licensed by the Home Office to conduct research and development of cannabis-based medicines for conditions such as multiple sclerosis and neuropathic pain. The cannabis-based spray Sativex® is approved in the United Kingdom, Austria, Czech Republic, Denmark, Germany, Spain, Sweden, Canada, Israel and New Zealand for the relief of the symptoms of spasticity in multiple sclerosis. In Canada, Sativex® is also used for the symptomatic relief of neuropathic pain in multiple sclerosis and for the relief of pain in cancer. GW has a promising pipeline of other cannabis based products in Phase 2 development.
Under the guidance of experienced Regulatory Affairs professionals, the Regulatory Specialist will be involved in the preparation of clinical trial documents for submission to regulatory authorities in countries worldwide. The successful applicant will also be involved in the preparation of marketing authorisation applications and maintenance activities.
Suitable candidates should have a life-science degree, excellent attention to detail, be well-organised and able to deal with conflicting priorities. The candidate must also be a confident communicator with good writing skills.
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 new 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.
To apply please send your CV and covering letter to:
Crissy Clark
GW Pharma Ltd
Building 114
Porton Down Science Park
Salisbury
Wiltshire
SP4 0JQor by email to:ca@gwpharm.com