ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
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.
Manager, Pharmacovigilance role
Summary:
Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group. (E.g. may be able to provide services for Serious Adverse Events (SAE)/Adverse Reactions /Medical Device Report management in writing or by phone, periodic safety reports, adjudication, coding, product complaints.) Supports departmental initiatives and development of SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance. Maintains familiarity with current industry practices and regulatory requirements that affect services provided by Pharmacovigilance. Ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and SOPs.
Responsibilities:
• Supports direct reports in monitoring of their projects to assure company profitability and associated project goals and objectives are being met.
• Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.
• Identifies and implements improvements of processes within the assigned service are through review of project specific plans and their implementation; recommends improvement plans to project.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.
• Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.
• Builds and aligns a technical team to perform critical operating tasks to achieve results.
• Identifies and implements process improvements and other ways to improve efficiencies.
• 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.
• Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.
• Liaises with other functional managers to ensure consistency of safety management approaches within the company.
• Maintains familiarity with current industry practices and regulatory requirements that affect services provided respective service area.
• Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, group-related project tasks; provides leadership in the delivery of related services to clients.
• Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
• Creates an environment that encourages learning, self-improvement and career development for staff.
• Supports the development and implementation of training for Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, or other personnel within the assigned service area.
• Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
• Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
• Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management.
• Participates in task forces to implement process improvement initiatives.
• Builds teamwork and improves process and productivity by working within and across functional areas.
• Develops company employees to ensure high quality work performance and retention of high quality employees.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development.
• Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities.
• Involved in the recruiting processes for new employees in the assigned service area.
• Assists with bringing new business opportunities to the company and maintaining existing clients’ relationships for repeat business.
• Interacts with clients and participates in client meetings as necessary to support and maintain new business.
• As assigned, participates in business development initiatives, including presentations and proposal development.
• Ensures that timely and accurate information is submitted on all proposal efforts.
• Participates in business development initiatives, including presentations and proposal development.
• Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed.
• Prepares Standard Response letters, including conducting literature search, article summary etc.
• Responsible for vendor management (e.g. LPPharmacovigilance)
• Supports Qualified Person for Pharmacovigilance as required
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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