Summary: The Freelance Director, Drug Safety & PV will lead pharmacovigilance and drug safety activities for clinical development programs, focusing on safety surveillance and risk management. The role requires a Qualified Physician with experience in Phase III trials and involves presenting safety data to stakeholders and overseeing regulatory submissions. This position offers a chance to significantly impact a growing biotech company. The contract is remote and has a high likelihood of extension.

Key Responsibilities:

• Develop and maintain expertise in product safety profiles and strategic context.
• Lead safety surveillance, signal detection, and risk management activities.
• Provide medical evaluation of safety reports with study teams.
• Act as a safety expert for regulatory submissions 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.

Key Skills:

• 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).

Salary (Rate): £100

City: undetermined

Country: United Kingdom

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other