Executive Director, Drug Safety Surveillance
About the position Responsibilities • Manage the overall planning, oversight and timely development and submission of safety-related regulatory documents including DSURs/IND Annual Reports, PADERs, PSURs/PBRERs, and other global periodic safety reports. • Support the development and review of appropriate safety sections of key product documents including IBs, study protocols, ICF, CCDS, RMP, and REMS. • Perform routine review and evaluation of aggregate safety data from ongoing studies and provide summary results in collaboration with Drug Safety Physicians. • Support safety signal detection and assessment activities, including identification and validation of possible trends and concerns related to Ionis products. • Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, and track all safety-related activities. • Oversee literature surveillance, identify safety issues from published medical literature, and summarize relevant publications for inclusion in safety periodic reports. • Support projects or initiatives from cross-functional groups ensuring adequate safety support and timely updates of safety information. • Develop Ionis Drug Safety infrastructure, including new safety projects and set-up of safety systems. • Provide direct management and mentorship to Safety Surveillance Scientists. • Monitor industry best practices and recommend changes to existing departmental policies and systems. Requirements • Master's degree in life sciences with a minimum of 12 years' experience in pharmacovigilance in a pharmaceutical or biotechnology company; Doctorate degree preferred with at least 8 years' experience. • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements. • Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting and signal detection activities. • Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize scientific data. • Strong proficiency in verbal and written communication with great attention to detail and ability to meet project deadlines. • Ability to work independently, manage work priorities, and build collaborative team relationships. Benefits • Comprehensive health insurance • 401k retirement plan • Flexible scheduling options • Professional development opportunities • Paid holidays and vacation time Apply tot his job Apply tot his job