Safety Partner

CK Group are recruiting for a Drug Safety Partner to join a pharmaceutical company at their site based in Welwyn on an initial 12-month contract basis, working 2 days in the office. Role is Inside IR35

The Role: The main purpose of the role willbe to

• Oversee of AE reports being processed accurately and within required deadlines and ensuring that all reportable cases are submitted to the MHRA
• Maximising the quality of information captured relating to ICSRs and ensuring that this is recorded accurately and in a timely manner and in accordance with global and local SOPs and related documents
• Quality checking of the data entry and submission of ICSRs and workflow manager responsibilities

Further responsibilities will include:- Reviewing clinical trial documentation and publications to ensure Drug Safety compliance and performing the analysis of safety data originating from locally managed studies/programmes

• Writing and reviewing safety reports and safety regulatorydocumentation and reviewing safety data outputs for local signal detection
• Actively partnering with the business in providing Pharmacovigilance and product safety expertise and representing new and ongoing activities which includes Non-Interventional Studies (NIS), Interventional Clinical Trials (ICT), digital activities and activities requiring the spontaneous PV clause

Your Background: To succeed in this role, you will come from a broad Drug Safety background with a Life Science degreeApply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53721 in all correspondence.