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Associate Director - Safety Scientist - Home based - East Coast

Associate Director - Safety Scientist - Home based - East Coast

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Associate Director - Safety Scientist - Home based - East Coast

MSI Pharma are working with an innovative clinical-stage bio-pharmaceutical with a strong leadership group to source a Senior Safety Scientist to report into the head of the safety organisation.

The company currently have a fully outsourced model but are in the process of bringing in-house a number of elements and this role forms a strategic part of this plan.

The role

Clinical Safety:

  • Support filling preparation activities
  • Lead preparation of safety plans with commercial partners
  • Provide input and represent safety in protocol development
  • Respond to regulatory queries
  • Oversee the current safety vendors and provide QC oversight
  • Review incoming escalated cases

Post Market Safety:

  • Facilitate the transfer of signal detection in-house
  • Support safety monitoring and risk management activities
  • Ensure correct communication of safety information
  • Author/support compilation of aggregate reports
  • Support and oversee PVAs and SDEAs

Requirements

The client are looking for candidates with the following experience:

  • Bachelor level degree in a Life Science discipline or similar
  • 5 years' experience in Safety Science
  • Experience and strong understanding of Signal Detection, Risk Management & Vendor Management
  • Experience working in smaller/growing organisations