Drug Safety Physician

About the Role

Our client is looking for a highly qualified and experienced Drug Safety Physician to join their remote-based global pharmacovigilance team. In this critical role, you will provide medical expertise for the assessment of adverse events, contribute to signal detection and validation, and play a key part in risk management strategies for the company's pharmaceutical portfolio. This position offers the unique opportunity to work from home while contributing to the safety of medicines used worldwide, ensuring patient well-being and regulatory compliance across all markets.

Key Responsibilities

• Provide medical assessment and interpretation of individual case safety reports (ICSRs) and aggregate safety data.
• Lead signal detection and validation activities, identifying potential new safety risks associated with company products.
• Contribute medical expertise to the development and updating of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Review and approve periodic safety update reports (e.g., PSURs, DSURs) and other regulatory safety submissions.
• Act as the medical point of contact for safety inquiries from regulatory authorities and internal stakeholders.
• Collaborate with clinical development, regulatory affairs, and other departments on safety-related aspects of drug development and lifecycle management.

Requirements

• Medical Doctor (MD) or equivalent medical degree, with relevant postgraduate training and board certification in a relevant specialty.
• Extensive experience (5+ years) in pharmacovigilance or drug safety, with a strong clinical background.
• Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.
• Experience with safety database systems and data analysis.
• Excellent medical judgment, analytical skills, and ability to interpret complex scientific and clinical data.
• Strong written and verbal communication skills, with the ability to effectively convey complex medical information.
• This is a fully remote position, requiring a dedicated home office setup and the ability to work independently.

Benefits

• Highly competitive salary and bonus structure commensurate with experience.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off and company holidays.
• Support for continuing medical education and professional development.
• The flexibility of a remote-first work environment, contributing to global patient safety from Norwich or any suitable remote location.