Associate Director - 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.
- 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
- 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 neuropsychiatric 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.