Executive Director, Drug Safety Surveillance

About the position 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 tot his job Apply To this Job