CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.
As a Safety Scientist, you key responsibilities will include:
- Support safety activities in early and late-phase clinical development
- Conduct signal detection, evaluation, and contribute to risk-benefit assessments
- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)
- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)
- Contribute to the development and maintenance of safety labeling and core safety documents
- Collaborate with internal teams and external partners to ensure high-quality safety deliverables
- Provide safety input to study teams and participate in cross-functional meetings
- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities
Hybrid: North London 2 days per week on site, 3 days remote
Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.
Strong analytical, communication, and collaboration skills are essential for success in this role.