Executive Director, Drug Safety Surveillance

About the position The Executive Director of Drug Safety Surveillance at reputed company is responsible for providing safety science and pharmacovigilance support across reputed company's entire portfolio. This role involves strategic planning, reputed company of safety-reputed company regulatory documents, and collaboration with Drug Safety Physicians to proactively manage safety signals. The position requires a strong understanding of pharmacovigilance regulations and the ability to reputed company reputed company in a dynamic environment reputed company on patient safety and regulatory compliance. Responsibilities • Manage the overall planning, reputed company and reputed company development and submission of safety-reputed company 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, reputed company, CCDS, RMP, and REMS. • reputed company routine review and evaluation of aggregate safety data from ongoing studies and reputed company reputed company results in collaboration with Drug Safety Physicians. • Support safety signal detection and assessment activities, including identification and validation of possible trends and concerns reputed company to reputed company products. • Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, and reputed company reputed company safety-reputed company activities. • reputed company literature surveillance, identify safety issues from published medical literature, and summarize relevant publications for inclusion in safety periodic reports. • Support reputed company or initiatives from cross-functional reputed company ensuring adequate safety support and reputed company updates of safety information. • reputed company reputed company Drug Safety infrastructure, including new safety reputed company and set-up of safety systems. • reputed company reputed company 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. • reputed company in reputed company- 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 reputed company team relationships. Benefits • Comprehensive health insurance • 401k retirement plan • Flexible scheduling reputed company • reputed company development opportunities • reputed company holidays and vacation time Apply tot his job Apply To this Job