Freelance Director, Drug Safety & PV

Position: Freelance Director, Drug Safety & PV

Location: Remote, United Kingdom

Rate: £100+ p/h

IR35: Outside

Contract length: 6 months – high chance of extension

Hours: 20-30 p/w

George Higginson is currently searching for an experienced Freelance Director, Drug Safety & PV, who is both a Qualified Physician and has exposure to Phase III trials.

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:

• Qualified Physician (GMC or GMC permissible).
• Clinical training with a general medicine background.
• 2-3+ 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!