A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Drug Safety Specialist to join their Uxbridge team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide. Under the direction of the Sr. Manager of Compliance, this individual will be responsible for contributing to the ongoing support and functioning of the GDSRM Safety Ops group, primarily within the area of Compliance and business partner contract support.
- Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
- Translation of source documents as needed
- Data Entry and Assessment
- Conduct full data entry from source document
- Execute QC on key fields of serious cases and update ARISg as needed
- Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
- Identify SUSARs from blinded clinical studies and alert Drug Safety Management to the need for unblinding
- Create narrative as defined by conventions
- Create draft company comments for serious cases
- Rank events and determine dechallenge/rechallenge information
- Develop follow-up needs for AE reports and create follow-up letters, review and update generated follow-up letters as appropriate
- Update communication log in ARISg as needed
- Authorise (approve) non-serious cases
- Notify Workflow/Drug Safety Manager if any delay in case processing is observed
- Review and resolve ARISg validation errors
- Medical Review
- Support the identification of corrections and creation of updates in ARISg following medical review
- Discuss issues with medical reviewers as appropriate
- Contribute to conventions and process documentation as required
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.