Drug Safety Physician

About the Role

Our client is recruiting a dedicated Drug Safety Physician to join their pharmacovigilance department based in Cardiff . In this critical role, you will be responsible for the medical assessment of adverse event reports, ensuring patient safety throughout the lifecycle of pharmaceutical products. You will work closely with regulatory affairs and clinical operations teams to monitor drug safety profiles and contribute to risk management strategies. This on-site position is ideal for a physician with a strong interest in patient safety and regulatory compliance, providing a unique opportunity to contribute to safeguarding public health within a reputable pharmaceutical organization.

Key Responsibilities

• Conduct medical reviews and assessments of adverse event case reports from various sources.
• Determine the causality of reported adverse events and ensure accurate coding using relevant dictionaries (e.g., MedDRA).
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory safety documents.
• Collaborate with clinical teams to ensure safety monitoring plans are robust and effectively implemented.
• Participate in signal detection and risk assessment activities, recommending appropriate risk management measures.
• Provide medical expertise on drug safety matters to internal stakeholders and regulatory authorities.

Requirements

• Medical Doctor (MD) or equivalent qualification with a valid medical license to practice.
• Minimum of 3 years of experience in drug safety, pharmacovigilance, or a related clinical field.
• In-depth understanding of global pharmacovigilance regulations and guidelines.
• Experience with adverse event reporting systems and medical terminology.
• Strong analytical skills and the ability to interpret complex medical data.
• Excellent written and verbal communication skills, with the ability to present medical information clearly.

Benefits

• Competitive salary and benefits package.
• Opportunity to work on diverse pharmaceutical products.
• Professional development and training opportunities.
• Generous annual leave and sick leave policy.
• Collaborative and supportive team environment in Cardiff .