Drug Safety Physician

About the Role

Our client is seeking a qualified and experienced Drug Safety Physician to join their global pharmacovigilance team, offering a fully remote working arrangement. This critical role involves providing medical expertise for the safety assessment of pharmaceutical products throughout their lifecycle. You will lead signal detection, case review, and risk management activities, ensuring patient safety and regulatory compliance. This is an exceptional opportunity for a physician with a passion for drug safety who thrives in a remote work environment, can make sound medical judgments based on complex data, and is dedicated to upholding the highest standards of patient well-being across Bristol and international markets.

Key Responsibilities

• Provide medical assessment of adverse event cases and safety data.
• Lead and participate in signal detection and evaluation activities to identify potential drug safety issues.
• Contribute medical expertise to the development of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Review and approve safety-related regulatory submissions, such as Periodic Safety Update Reports (PSURs).
• Serve as a medical expert for pharmacovigilance inquiries from regulatory authorities, internal departments, and external stakeholders.
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs.

Requirements

• Medical Doctor (MD) or equivalent degree (e.g., DO). Board certification in a relevant specialty is a plus.
• Minimum of 5 years of experience in drug safety and pharmacovigilance within the pharmaceutical industry.
• Strong understanding of global pharmacovigilance regulations, GVP, and safety reporting requirements.
• Proven experience in medical assessment of adverse events and signal evaluation.
• Excellent medical judgment, analytical skills, and the ability to work independently in a remote setting.
• Exceptional written and verbal communication skills for remote collaboration and reporting.

Benefits

• Highly competitive physician salary and bonus program.
• Comprehensive medical, dental, and vision insurance plans.
• Generous paid time off and holidays.
• Allowance for home office equipment and technology support to facilitate remote work.
• Support for continuing medical education (CME) and professional development.