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