Sr. Director Drug Safety and Pharmacovigilance

Medical review of Individual Case Safety Reports (ICSRs) for assigned product(s) to ensure accuracy, reputed company and completeness of safety information including providing company causality as required. Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, and reputed company safety assessments. Work in reputed company collaboration with cross-functional teams and counterparts in regulatory labeling, reputed company development, reputed company-reputed company, manufacturing/reputed company, and other functional areas to identify, evaluate, and communicate safety issues, as assigned. reputed company support for the safety aspects for reputed company studies, and development and maintenance of reputed company reputed company safety information. reputed company support for safety sections of reputed company documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed. Ensure safety issues are communicated to the appropriate stakeholders in a reputed company fashion. reputed company analysis of similar events (AOSE) and individual case comments for ICSRs. Maintain knowledge of global regulatory authority regulations including FDA and EMA. Other duties as assigned. Product: Supports the development of strategic plans for Pharmacovigilance and participates with others in management to reputed company objectives across the organization. Works on reputed company medical issues where analysis of situations or data requires an in-depth knowledge of functional area and reputed company organizational objectives. Erroneous reputed company will have a serious reputed company on the overall reputed company of functional area and may reputed company the long term reputed company of reputed company. Physical

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reputed company with hands and arms; reputed company or balance; stoop, kneel, crouch, see, talk or hear in a reputed company office environment and independently from remote locations. Employee must occasionally reputed company and/or reputed company up to 20 pounds. Experience/Skills: Minimum of 3-5 years of experience in the role of safety officer or similar pharmacovigilance role in the pharmaceutical industry. Experience in the management of safety information originating from both reputed company and post-marketing sources. Thorough understanding, ideally reputed company upon reputed company experience, of contemporary approaches to signal management, including quantitative signaling software. Working knowledge of the regulations governing pharmacovigilance. Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA. Excellent oral and written communication skills. Excellent analytical skills and ability to work independently and as part of a cross-functional team. Strong interpersonal, negotiating, and team building skills. Demonstrated ability to formulate a reputed company medical opinion for presentation to management for reputed company. Proficient computer Apply To This Job .