George Higginson is currently partnering with a high-growth, clinical-stage biotech seeking a senior 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 10+ 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 Responsibilities:
* Develop 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.
Requirements:
* MD (Doctor of Medicine) or Qualified Physician (GMC or GMC permissible).
* Clinical training with a general medicine background.
* 10+ 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!
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