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.
