Drug Safety Physician (Pharmacovigilance)

About the Role

Our client is seeking a qualified and experienced Drug Safety Physician to join their pharmacovigilance department in Southampton . In this critical role, you will be responsible for the safety assessment of assigned pharmaceutical products, ensuring patient safety and compliance with global regulatory requirements. You will play a key part in signal detection, risk management, and regulatory reporting of adverse events. This is an excellent opportunity for a medically qualified professional to make a significant impact on drug safety within a forward-thinking pharmaceutical company.

Key Responsibilities

• Perform medical assessment of adverse event reports and determine seriousness and expectedness.
• Contribute to signal detection and management activities, identifying potential safety issues.
• Prepare and review aggregate safety reports (e.g., PBRERs, DSURs) for regulatory submissions.
• Provide medical expertise for risk management plans (RMPs) and risk-benefit assessments.
• Liaise with regulatory authorities regarding drug safety matters.
• Collaborate with clinical development, regulatory affairs, and other departments on safety-related issues.

Requirements

• Medical Doctor (MD) or equivalent medical degree with unrestricted medical license.
• Minimum of 3 years of experience in drug safety or pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., CIOMS, ICH).
• Experience in performing medical assessments of adverse events and signal detection.
• Strong understanding of clinical pharmacology and therapeutic areas.
• Excellent written and verbal communication skills, with the ability to articulate complex medical information clearly in Southampton and internationally.

Benefits

• Competitive salary and executive bonus program.
• Comprehensive healthcare, dental, and vision coverage.
• Significant pension plan with employer matching.
• Relocation assistance may be available.
• Opportunity to work with a leading pharmaceutical company focused on patient safety in Southampton .