Safety Risk Management Lead

1 week ago

Cambridge, Cambridgeshire, United Kingdom Advanced Resource Managers Full time

Job Description

Advanced Resource Managers is currently supporting a long-standing client in their search for a Safety Risk Management Lead- EMEA on a contract basis. Our client is a global leader in advancing science and improving health.

Key Responsibilities:

  • Lead safety signal management activities, including detection, validation, and prioritisation of safety data
  • Conduct reviews of emerging safety data across diverse sources, including individual case reports, aggregate reports, and literature
  • Oversee and participate in the planning, preparation, and review of periodic safety reports (DSUR, PSUR, PADER)
  • Collaborate with key stakeholders to develop and execute safety signal and benefit-risk management strategies
  • Provide guidance on study-related documents and participate in safety data presentation and analysis
  • Mentor junior team members and contribute to the development of processes and tools to enhance safety oversight

Requirements:

  • Bachelor's or Master's degree in pharmacy, nursing, healthcare, or a related field
  • 10+ years of pharmacovigilance experience with strong expertise in signal detection and safety risk management
  • In-depth knowledge of pharmacovigilance regulations for marketed products and clinical trials across major markets
  • Proficiency with Oracle Empirica and MedDRA, along with advanced skills in Microsoft Office
  • Strong project management skills and ability to manage complex issues with limited intervention

Please note that this is a contract position with Advanced Resource Managers.

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