Senior Manager, Pharmacovigilance

<p><span>ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.</span><br/><span>With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.</span><br/><span>Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.</span><br/> </p><p><b>Description:</b></p><p></p><p>• Monitors projects to assure company profitability and associated project goals and objectives are being met.<br/>• May serve as the main point of contact for the customer for the life-cycle of assigned stand alone projects and programs, and the main pharmacovigilance point of contact for assigned full-service projects<br/>• Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.<br/>• Identifies and implements improvements of processes within own service area through review of project specific plans and their implementation; recommends improvement plans to projects.<br/>• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.<br/>• Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.<br/>• Identifies and implements process improvements and other ways to improve efficiencies.<br/>• Provides technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans, in close cooperation with project team during set-up phase.<br/>• Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.<br/>• Liaises with other functional managers to ensure consistency of pharmacovigilance approaches within the company.<br/>• Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned service area.<br/>• Reviews Pharmacovigilance Associate, Pharmacovigilance Specialist and/or Pharmacovigilance Assistant group-related project tasks; provides leadership in the delivery of related services to clients.<br/>• Supports direct reports in identification of out of scope activities and process <span>efficiency/improvement</span> needs or implement contract amendments/change orders as required<br/>• Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.<br/>• Creates an environment that encourages learning, self-improvement and career development for staff.<br/>• Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.<br/>• Builds teamwork and improves process and productivity by working within and across functional areas.<br/>• Ensures staff development and performance feedback are provided through activities such as mentorship and career development.<br/>• Involved in the recruiting processes for new employees within the assigned service area.<br/>• Assists with bringing new business opportunities to the company and maintaining existing clients’ relationships for repeat business.<br/>• Interacts with clients and participates in client meetings as necessary to support and maintain new business.<br/>• Participates in business development initiatives, including presentations and proposal development.<br/>• Ensures that timely and accurate information is submitted on all proposal efforts.<br/>• Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.<br/>• Coordinate interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)<br/>• Acting as a Subject Matter Expert (SME) for various technologies or processes<br/>• Develops and delivers training courses on Pharmacovigilance related topics to ICON employees within and outside Pharmacovigilance, as well as to external parties (investigators, clients).<br/>• Displays an industry presence by:<br/>• Writing articles for industry publications<br/>• Giving presentations at industry conferences<br/>o Obtaining industry certifications<br/>• Represents the assigned Pharmacovigilance service area as part of global initiatives impacting Pharmacovigilance, and makes decisions autonomously, with little direct supervision required.</p><p></p><p><b>Requirements:</b></p><p></p><ul><li>Thorough working knowledge of local and global medical device Health Authority regulations, guidelines, policies and ICH Guidelines</li>