Safety Risk Management Lead

1 month ago


Cambridge, United Kingdom Advanced Resource Managers Full time

Contract - 6 months

Full FTE

Location - Cambridge (onsite)


Advanced Resource Managers are 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. The Safety Risk Management Lead will oversee and manage the safety of drugs in clinical trials by identifying, analysing, and managing safety risks.


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


Responsibilities:

  • 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 apply if you would like to learn more about this opportunity.



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