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Job Location | Cambridge |
Education | Not Mentioned |
Salary | £300.00 - £400.00 per day |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
Manager Pharmacovigilance & Epidemiology (PVE12 Month contract based in CambridgeThe Pharmacovigilance and Epidemiology (PVE) department is a global function that is part of Research and Development w. The main Pharmacovigilance activities of PVE are centered at three sites: 2 in the USA and one in Cambridge in the UK.PVE Operations - This group is responsible for case processing from receipt through to submission to external parties and is also responsible for the operational support of clinical studies.Medical Safety Science - This group covers the medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection.Epidemiology - This group provides epidemiological support throughout all stages of a product lifecycle.Standards and Collaborations (S&C) is the group where the vacancy exists, and the role is based in Cambridge UK. This group is responsible for safety language in contracts, vendor oversight of safety information reporting for global Patient Assistance and Support Programs, market research and social listening projects, authoring Pharmacovigilance agreements (PVA) with license partners and CROs, audit and inspection readiness/support, pharmacovigilance training, Management of the Pharmacovigilance System Master File, PV compliance and quality measures and managing the Pharmacovigilance Responsible Persons with global affiliates and supporting PV in Distributor countries across the world.Sciences is seeking an ambitious individual to join the Standards and Collaborations team as a Manager, responsible for creating, update and maintenance of Clinical Trial Reporting Procedures (CTSRPs) between us and contracted CROs for Clinical Trials globally.This is a role responsible for ensuring timely and appropriate safety exchange between us and contracted CROs for our Sponsored Clinical Trials to meet Regulatory Reporting timelines in applicable countries. The individual will be responsible for following internal processes to ensure CTSRPs are sufficient to meet compliance with CT and GVP standards.At a minimum, the ideal candidate will possess:Scientific background with a medico-scientific university degree
Keyskills :
Clinical Trials Epidemiology Pharmacovigilance medical projects clinical drug safety