Head Of Drug Safety
About the Company
Accomplished biotechnology (BioTech) company
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Head of Drug Safety to lead its pharmacovigilance function and ensure the safety and well-being of patients. The successful candidate will be responsible for all aspects of drug safety and pharmacovigilance, including safety data review, signal detection, risk communication, and the mitigation of potential risks. This role requires providing medical and drug safety expertise to support decision-making, addressing safety-related topics as part of the clinical leadership team, and overseeing a growing safety operations team. The Head of Drug Safety will also be involved in safety monitoring and assessment activities, such as providing input for regulatory agency questions, and will be accountable for the safety data management and reporting system. Applicants must have an MD and a minimum of 7 years' experience in drug safety-related activities, with a preference for those with a background in pharma or biotech. The role demands demonstrated leadership abilities, clinical trial experience, and a strong knowledge of global regulatory requirements for safety reporting and risk management. Familiarity with medical concepts in hematology/oncology is highly desirable. The ideal candidate will have excellent communication skills, the ability to multitask in a fast-paced environment, and a proactive approach to ensuring the effectiveness of the drug safety system. Responsibilities also include leading the development of safety-related documents, ensuring audit readiness, and fostering strong relationships both internally and with external partners.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions