Senior Patient Safety Physician
An exciting opportunity has arisen within a leading global pharmaceutical organisation for an experienced (Senior) Global Patient Safety Physician to join their growing Cardiovascular, Renal & Metabolism (CRM) Patient Safety & Pharmacovigilance team. This is a highly visible, global position operating at the intersection of Patient Safety, Clinical Development, Regulatory Affairs, Medical Affairs and Evidence Generation. The role offers the opportunity to shape the benefit-risk profile of innovative medicines from late-stage development through regulatory submission and ultimately to patients.
Working within one of the industry's most exciting cardio-renal-metabolic portfolios, you will support programmes spanning across cardiovascular risk reduction, chronic kidney disease, heart failure, obesity, liver disease, kidney disease, and other metabolic disorders, contributing to the development of medicines designed to transform standards of care for patients globally.
Unlike traditional operational pharmacovigilance positions, this role focuses on strategic safety leadership, aggregate data interpretation, benefit-risk assessment and scientific partnership across global development teams. You will work alongside Clinical Development Leads, Regulatory Leads, Statisticians and Medical Affairs colleagues, helping drive critical decisions throughout the product lifecycle.
Key Responsibilities
- Provide strategic medical-scientific input into the safety assessment and benefit-risk evaluation of assigned development assets
- Lead and contribute to integrated Patient Safety & Pharmacovigilance activities across development and post-marketing programmes
- Develop and implement safety evidence generation and risk management strategies
- Monitor, evaluate and continuously develop product safety profiles using aggregate clinical and post-marketing data
- Interpret clinical trial safety data for regulatory submissions and development programmes
- Collaborate closely with Clinical Development, Medical Affairs, Epidemiology and Regulatory Affairs teams to support global development strategies
- Contribute to regulatory documentation, including Risk Management Plans, DSURs, PSURs, Investigator Brochures and Clinical Overviews
- Present safety recommendations to senior management and governance committees
Essential Experience
- Medical Doctor (MD) qualification
- Significant experience within Patient Safety, Pharmacovigilance and Risk Management within the pharmaceutical industry
- Experience supporting late-stage clinical development programmes
- Regulatory submission experience
- Experience supporting global development programmes and benefit-risk assessment activities
- Strong understanding of international pharmacovigilance regulations and compliance requirements
If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki for further details or email your CV today.
- By email: vicki.taggart@hayburysearch.com
- By phone: +44 (0)1273 059 648 or +44 (0) 7881 555 382
