This is an attractive Drug Safety Specialist job vacancy at a global biotechnology innovator specialising in disease areas which have unmet medical needs. This exciting new position will be based at their London site. The company have many commercial products and an excellent pipeline of drug candidates in development. With a rich history of innovation and exponential growth plans they are looking to expand their Pharmacovigilance team with a Drug Safety Specialist. 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. To manage safety data within the company’s central safety database covering both pre-and post-market activities. To ensure compliance with internal case processing timelines. A regional role based in the UK.
- 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
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.