BioTalent is collaborating with Big Pharma client based in to appoint a permanent Safety Director who will span the portfolio for molecules and medical devices. This role will suit someone with a strong and successful track record in post marketing safety evaluation, new drug applications, regulatory filings, benefit & risk assessment and safety risk management

You will be Responsible For:

• Expertise in clinical interpretation of safety assessments and device safety reports.
• High level response to regulatory authority requests
• Develop safety materials and reports
• Safety assessment for signals or issues
• Risk management, Investigator brochures etc

You will bring the following:

• Health care professional qualifications or LifeScience degree in biomedical engineering / medical devices OR combination product experience in industry
• Evidence of process improvement implementation, patient safety, vigilance and clinical/patient risk management
• Ability to train and manage others in global matrix environment
• Expertise of EU MDR, FDA and other device related regulations

If this role is for you please be in touch to dominic.pritchard@biotalent.com or +44 203 828 6059