This Drug Safety Scientist job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Buckinghamshire, UK. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.
Job Role and Responsibilities:
- Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.
- Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
- Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
- Provision of safety information/acknowledgement to marketing partners/other third party partners/Global Medical Safety within the internal and contractual timelines
- Requesting additional information from multiple sources, both internal and external to the Company
- Assist with assessment of incoming information from multiple sources, both internal and external to the Company
- Assist in the quality review of data captured in the Global Safety Database
- Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and
- Quality review of expedited assessments prior to submission
- Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines
- Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
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 Lisa Edgar on +44 0203 7520 313 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.