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Senior Safety Scientist

Senior Safety Scientist

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Senior Safety Scientist

  • Location:

    Connecticut

  • Sector:

    Pharmacovigilance

  • Contact:

    Edward Jessel

  • Salary:

    US$140000 - US$175000 per annum

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/03711_1618474853

  • Published:

    27 days ago

  • Startdate:

    ASAP

Senior Safety Scientist - Permanent - 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 organization.
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 is Smaller/growing organisations


More information about the client


The Clients portfolio is comprised of innovative, late stage products targeting neurological and neuro-psychiatric diseases. Their progress is fuelled by an entrepreneurial structure and an impressive range of experience in drug development along with the confident support of top-tier investors.