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CK Group
,
Welwyn Garden City, Hertfordshire
Senior Safety Scientist
Overview
CK Clinical are recruiting for a Senior Safety Scientist to join a research-focused healthcare company at their site based in Welwyn on a 12 month contract basis. The Company: Our client is globally renowned pharmaceutical company with their UK Pharmaceutical Head Office situated in Welwyn, Hertfordshire. The site is accessible by motorways & airports as well as being a 30-minute train ride to London, access is easy. There are well over 1000 people occupying their site in Welwyn. The Role: The main purpose of the role will be to: - Support early and late phase development activities as a member of the safety team providing essential safety oversight and input into all aspects of study management across the entire development portfolio. - Be responsible for individual and aggregate case reporting activities including ICSR case management. - Be responsible for signal detection and management activities. Further responsibilities will include: - Contributing to regulatory authority submissions; reviewing safety data and preparing relevant sections. - Coordination and collaboration with vendors servicing Safety Science. - Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS. Your Background: To succeed in this role, you will come from Life Science degree background with experience in a healthcare related field or equivalent experience. - Work experience in pharma safety, pharmacovigilance. - Understanding of GxP and regulated processes and end to end clinical trial lifecycle. - Perform application of data analysis/statistical methods to evaluate, interpret and present scientific data with clarity. For more information or to apply for this Senior Safety Scientist position, please contact CK Group, quoting job ref 48018. It is essential that applicants hold entitlement to work in the UK.