George Higginson is currently partnering with a high-growth, clinical-stage biotech seeking a senior Contract Director of Drug Safety & PV to lead safety strategy across late-stage clinical programs.This is a visible, hands-on leadership role for a Qualified Physician/Medical Doctor with 8+ years’ experience in Drug Safety / Pharmacovigilance, including deep Phase III exposure.You will serve as the Pharmacovigilance/Drug Safety Lead for safety surveillance & risk management activities for their clinical development programs.Main ResponsibilitiesDevelop and maintain expertise in product safety profiles and strategic context (e.g., disease, competitors, mechanism of action).Lead safety surveillance, signal detection, and risk management, presenting key issues to internal and external stakeholders.Provide medical evaluation of safety reports (ICSRs) with study teams.Act as a safety expert for regulatory submissions (BLA/MAA) and related content.Oversee periodic safety reports, investigator communications, and regulatory responses.Lead clinical safety and benefit-risk sections in regulatory documents and meetings.Develop Risk Management Plans and represent safety on cross-functional teams.Provide safety training to company employees.RequirementsMD (Doctor of Medicine) or Qualified Physician (GMC or GMC permissible).Clinical training with a general medicine background.8+ years in clinical safety/pharmacovigilance, especially in phase III trials.Expertise in safety assessments, regulatory reports, and submissions.Experience presenting safety data in marketing and biologics license applications.Background in dermatology, rheumatology, immunology, or GI is a plus.Strong knowledge of international pharmacovigilance and regulatory requirements (UK, EU, US).This is a fantastic opportunity to be a key part of a true 'underdog' Biotech, helping to shape the future of the organisation while ensuring the delivery of top-quality clinical development programs.Apply today to take the next step in your leadership journey! #J-18808-Ljbffr