Drug Safety Physician

About the Role

Our client is seeking an experienced and board-certified physician with a specialization in Drug Safety and Pharmacovigilance to join their global medical affairs team, supporting operations from Sheffield . This senior role is responsible for the medical assessment of adverse event reports, signal detection, and ensuring the overall safety of our client's pharmaceutical products. You will play a critical role in safeguarding public health by providing medical expertise to interpret safety data, contribute to risk management strategies, and ensure compliance with global regulatory standards. This hybrid role involves strategic oversight and medical review, with flexibility for remote work balanced with occasional on-site collaboration.

Key Responsibilities

• Provide medical expertise for the assessment of serious adverse events and safety signals.
• Contribute to the development and content of risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Review and approve safety-related regulatory submissions, including aggregate reports (e.g., DSURs, CIOMs).
• Collaborate with clinical development, regulatory affairs, and other cross-functional teams on safety matters.
• Participate in medical expert reviews of clinical trial data and post-marketing safety data.
• Ensure adherence to global pharmacovigilance regulations and company policies, providing medical interpretation of requirements.

Requirements

• Medical Doctor (M.D. or equivalent) with board certification in a relevant specialty (e.g., Internal Medicine, Pharmacology, Neurology).
• Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry.
• Strong clinical background and ability to interpret complex medical and scientific data.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., GVP, FDA, EMA).
• Excellent analytical, critical thinking, and decision-making skills.
• Effective communication and collaboration abilities, suitable for a hybrid work model.

Benefits

• Highly competitive physician salary and significant bonus eligibility.
• Comprehensive executive health benefits and a robust retirement savings plan.
• Support for professional development, including conference attendance and training.
• Flexible hybrid work arrangement, supporting work-life balance in the Sheffield area.
• Opportunity to influence global drug safety strategy and patient well-being.