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| Job Location | Stockley Park |
| Education | Not Mentioned |
| Salary | £25.00 - £30.00 per hour |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Contract, full-time |
*Safety Scientist - Global BioPharma - 6 -month contract - Uxbridge * My client is a Global Biopharmaceutical company that is focused on the development and discovery of innovative medicines and they have a position available for a Safety Scientist to join their PV and Epidemiology team for a 6-month contract.Specific ResponsibilitiesReview, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products.Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.Review, enter, and verify follow-up information for cases and make accurate determination of significant information.Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative.Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.Demonstrates general understanding of appropriate labeling documents for products.Ensures departmental workflow processes and timelines are followedPerform clinical trial reconciliation with minimal supervision from Manager or Sr Safety Specialist.Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr Safety Specialist.May triage and assign the incoming reports.Acts as a trainer and mentor for more junior staff members.Participate in some clinical trial activities with supervision from Manager or Sr Safety Specialist (i.e., protocol CRF reviews, clinical data management plan reviews, CRO agreements & SAE process flows, SAE reconciliation).To be considered for the role of Safety Scientist you will possess a Life science degree and have experience of Safety databases, data entry, case processing and clinical trials. You will have an understanding of medical terminology and the ability to summarize medical information and assess data and understand the medical/safety implications. Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred .Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on Required skills
Keyskills :
contract legislation berkshire ICSR case processing Pharmacovigilace