Executive Director, Drug Safety Surveillance
About the positionResponsibilities• 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