Drug Safety Physician

About the Role

Our client is seeking a qualified and experienced Drug Safety Physician to join their pharmacovigilance team, covering the Cambridge area. This hybrid role is central to ensuring the safety profile of pharmaceutical products by providing medical expertise in the assessment and management of adverse events. You will play a key role in evaluating safety data, contributing to regulatory submissions, and advising on risk management strategies. This position offers a significant opportunity to influence patient safety and product stewardship within a leading pharmaceutical organization.

Key Responsibilities

• Provide medical expertise for the assessment of adverse event reports, including causality assessment and seriousness evaluation.
• Contribute medical input to periodic safety reports (PSURs, PBRERs) and other regulatory submissions.
• Participate in signal detection and validation activities, recommending further investigations as needed.
• Advise on risk management plans (RMPs) and risk-benefit assessments for assigned products.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, on safety-related matters.
• Serve as a medical expert during regulatory authority interactions and inspections.

Requirements

• Medical Doctor (MD) degree with relevant post-graduate training and licensure.
• Significant experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• In-depth knowledge of global drug safety regulations and guidelines.
• Strong clinical judgment and the ability to interpret complex medical and scientific data.
• Excellent written and verbal communication skills, with the ability to effectively present medical information.
• Proven ability to work effectively in a hybrid environment and collaborate with diverse teams.

Benefits

• Highly competitive salary and executive-level benefits package.
• Hybrid work model providing flexibility and balance.
• Significant opportunities for professional growth and leadership in drug safety.
• Be instrumental in ensuring the safety of patients receiving innovative pharmaceutical treatments.
• Engage with a world-renowned research hub and contribute to cutting-edge pharmaceutical safety.