Hobson Prior are recruiting for a Safety Scientist Director join a multinational healthcare company at their offices in Hertfordshire. This position may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management.
- Contribute to development and deliver drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans.
- Assess clinical protocols, study reports, Investigator's Brochure, informed consent form and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication.
- Contribute to regulatory authority submissions by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.
- Partake in and provide input for Drug Monitoring Committees or internal monitoring committee meetings, as applicable.
- Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report/PBRER, EU renewal and other Safety Reports) and benefit-risk assessments.
- Support signal detection and evaluation activities.
- Excellent orientation towards cross-functional teamwork.
- Effectively work with remote partners on a global team.
- Strong written and verbal English communication skills.
- Bachelor’s Degree in life sciences required; Advanced Clinical/Science Degree preferred (e.g., PharmD, PhD, MSN, MPH, DDS, DVM, etc.).
- Minimum of 5 years of safety experience having worked on both development and post-approval products.
- Prior experience in the principles and techniques of data analysis, interpretation and clinical relevance.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.