Manager Pharmacovigilance

<p style="text-align:left"><b>Work Schedule</b></p>Third Shift (Nights)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Join us as Manager PV – And lead the efforts in managing and optimizing drug safety operations to ensure the highest standards of patient safety and regulatory compliance in clinical trials.<br /><br />What You’ll Do:<br />• Manage multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements.<br />• Maintain good communications with other functional groups concerning program and company issues. Collaborating with other employees in problem<br />solving and systems improvement.<br />• Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.<br />• Maintain a basic medical understanding of applicable therapeutic areas and disease states. May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites.<br />• Provide plans and accurate forecasts for all projects.<br />• Serve as a resource for other departmental managers and lead departmental initiatives.<br />• Prepare and present proposals.<br />• Manage staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.<br /><br />Education and Experience:<br />• Bachelor&#39;s degree or equivalent and relevant formal academic/vocational qualification to include 3&#43; years of safety experience<br />• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5&#43; years).<br />• 1&#43; year of leadership responsibility<br /><br />In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br /><br />Knowledge, Skills and Abilities:<br />• Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.<br />• Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents<br />• Strong knowledge of relevant therapeutic areas as required for processing AEs<br />• General knowledge of pathophysiology and the disease process<br />• Time management and project management skills<br />• Proficiency in Microsoft Office products and safety databases<br />• Good command of English and ability to translate information into local language where required<br />• Excellent oral and written communication skills<br />• Strong attention to detail and accuracy<br />• Strong critical thinking, problem solving and decision-making skills<br /><br />Working Conditions and Environment:<br />• Work is performed in an office environment with exposure to electrical office equipment<br />• Daily exposure to high pressure and intense concentration<br />• Daily interactions with clients/associates<br />• Long, varied hours on occasion<br />• Travel required occasionally domestic and/or international<br /><br />Physical Requirements:<br />• Frequently vertical and /or stationary for 6-8 hours per day.<br />• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.<br />• Frequent mobility required.<br />• Frequent bending and twisting of upper body and neck.<br />• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.<br />• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.<br />• Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.<br />• Frequently interacting with others, relates sensitive information to diverse groups.<br />• Ability to apply basic principles to solve conceptual issues.<br />• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.<br />• Regular and consistent attendance.<br /><br />Why Join Us?<br />When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.<br /><br />Apply today to help us deliver tomorrow’s breakthrough.</p><p></p><p></p><p></p><p></p>