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Job Location | Slough |
Education | Not Mentioned |
Salary | £18.00 - £22.00 per hour |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract, full-time |
Pharmacovigilance Associate - contract - Berkshire My client a top Pharmaceutical has a need for a Pharmacovigilance Associate to join their Safety team on an initial 3 month contract rolling.Within this role the Pharmacovigilance Associate will assist the Local Pharmacovigilance Manager in the provision of a comprehensive, accurate and timely local Pharmacovigilance management service for the UK and Ireland, within the framework of all applicable Standard Operating Procedures (SOPs).* Completing local pharmacovigilance (PV) activities in accordance with company Standard Operating* Procedures (SOPs) and Working Instructions (WIs).* Process Individual Case Safety Reports (ICSRs) and ensure timely completion of all case processing* activities in line with local regulations and company requirements.* Logging of adverse events into the Medical Information database as required and transferring reports to Global Patient Safety (GPS).* Determine and perform appropriate case follow-up, generating follow-up letters.* Working in collaboration with GPS on case processing activities. Filling ICSRs.* Provide information and conduct Pharmacovigilance training to staff and third-party providers. Reconciliation of all adverse event reports from Third Party service providers, distributors and licence partners.* Managing the local literature review process, conducting reviews (on-line and hardcopy non-indexed journals) to identify potential ICSRs and to identify safety information in accordance with company SOPs .* Perform monthly legislation scanning.* Maintain awareness of PV regulatory requirements and developments. Management of departmental email inbox.* Organise off-site archiving of PV case files.In order to be considered for this role, you will possess a Life Science Degree.You will have experience within Pharmacovigilance within the Pharmaceutical Industry, have a working knowledge of pharmacovigilance legislation and possess a good telephone manner and both oral and written communication skillsBefore 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