Hobson Prior are seeking a Safety Science Medical Director to join a global pharmaceutical company who focus on helping millions of patients by creating pioneering medicines and diagnostics tests.
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan, develop and maintain an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context.
- Contribute to development the product safety strategy and deliver drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans.
- Review of 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 the ongoing PV and Risk Management planning for designated products by preparation of the safety surveillance strategy.
- 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.
- Contributes to the development and oversight of the signal detection plan and the signal detection and assessment activities.
- Support the Safety Science Leader or Director/Group Head, Safety Science or be responsible for the development of the RMP/ISMP or Risk Evaluation and Mitigation Strategies for submission to regulatory health authorities.
- Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report/PBRER, Periodic Safety Update Report/PSUR, EU renewal and other Safety Reports) and benefit-risk assessments.
- Strong orientation towards cross-functional teamwork.
- Effectively work with remote partners on a global team.
- Strong written and verbal English communication skills.
- Completed MD degree and postgraduate training with 4 or more years of academic experience.
- Specialty training and board certification or equivalent (current or past) required or completed MD degree and postgraduate training with 2 or more years of clinical or academic experience and 2 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry.
- Demonstrated team leadership in industry or academic setting.
- Prior experience in the principles and techniques of data analysis, interpretation and clinical relevance.
- Experience publishing in a refereed journal preferred.
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle.
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.