Director of Drug Safety

Director of Drug Safety About the Company Join an accomplished biotechnology (BioTech) company dedicated to innovation and patient safety. Industry Biotechnology Type Privately Held About the Role The Company is actively seeking a Director of Drug Safety to spearhead its pharmacovigilance function. This pivotal role is essential for ensuring the safety and well-being of patients. As the successful candidate, you will lead all aspects of drug safety and pharmacovigilance such as safety data review, signal detection, risk communication, and risk mitigation strategies. You will provide critical medical and drug safety expertise to support decision-making, lead safety-related discussions on the clinical leadership team, and manage an expanding safety operations team. You will play an integral role in safety monitoring and assessment activities, contributing valuable insights for regulatory agency inquiries and overseeing the safety data management and reporting environment. Applicants must possess an MD and have a minimum of 7 years of experience in drug safety areas, preferably within the pharmaceutical or biotechnology sector. Strong leadership abilities, clinical trial expertise, and a solid understanding of global regulatory requirements for safety reporting and risk management are essential. Familiarity with medical concepts in hematology/oncology is highly advantageous. The ideal candidate will demonstrate exceptional communication skills, the capacity to multitask in a fast-paced environment, and a proactive approach to optimizing the drug safety system. Responsibilities also include leading the creation of safety-related documentation, ensuring readiness for audits, and nurturing strong partnerships both internally and externally. Hiring Manager Title Chief Medical Officer Travel Percent Less than 10% Functions Medical Care/Hospital Administration