My client based in the UK is urgently looking to hire a Global Safety Senior Medical Scientist. Please find the details below.
Job Title: Global Safety Senior Medical Scientist – Global Safety Physician
Contract: 12 months
• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison activities with affiliates and other internal company partners regarding products
• Supports and provides oversight with regards to safety in clinical trials
• Review and provide input on study protocols, statistical analysis plans, provide safety contents for regulatory filings. Reviews safety tables, figures, and listings from clinical studies.
• Support activities related to new drug applications and other regulatory filings
• Perform Signal detection, evaluation, and management
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO and pharmacovigilance scientist
• Prepare presentations to the Global Safety Team on safety issues
• Assist GSO in the development of risk management strategy and activities, and safety-related regulatory activities
MD or equivalent degree from an accredited medical school
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Clinical/medical research experience
• Product safety in the bio/pharmaceutical industry
• Inflammation and nephrology knowledge
Michael Bailey International is acting as an Employment Business in relation to this vacancy.