The company 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, to meet patient needs in a wide range of therapeutic indications.
Term
The company is now looking to recruit a new full-time permanent staff member to the Pharmacovigilance team which will be based 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.
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