Pharmacovigilance Project Manager

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.

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.

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.

The role:

The Pharmacovigilance Project Manager (PM) leads assigned Pharmacovigilance projects thorough all phases of ICON’s project's lifecycle to completeness, with a customer focused approach, and audit and inspection ready mindset. The Pharmacovigilance PM will lead project teams encompassed of cross-functional resources with a focus on delivering a completed high-quality project, within cost and on time. The Pharmacovigilance PM role is client facing for end-to-end Pharmacovigilance Projects that range from simple to complex and are carried out in a highly dynamic environment. The Pharmacovigilance Project Manager will be able to demonstrate and communicate knowledge of Pharmacovigilance, patient safety and regulatory / compliance activities with clients and project team.

Responsibilities:

• Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level. Ensure assignment of project specific training to project team.

• Primary liaison for client and project team for project level (time, scope, cost, quality, resource) matters.

• Manages & delivers assigned projects per fully executed contract, on schedule and on budget.

• Leads and directs cross-functional team leads/managers and third parties/vendors with some supervision and support. Ensure team is familiar with client and project scope.

• Responsible to develop and manage the Project Management Plan throughout the lifecycle of the project.

• Contributes to development, maintenance and approval of project plans.

• Guides and supports the project team-leads in prioritizing, trouble-shooting and contingency planning to ensure tasks are carried out in budget, on time and with quality by the project team.

• Have an overview and understanding of all tasks and actions to be delivered and completed including deadlines and milestones, as applicable.

• Leads and facilitates client and internal project meetings and responsible to approve meeting agenda and minutes. Ensure inclusion of applicable topics, actions and action item follow up.

• Liaises with functional leads/managers to optimize performance and utilization and manages feedback of project team members.

• Leads presentation of internal project status reviews (Pharmacovigilance Project Review or Finance Meetings) and is accountable for content development and action item follow up.

• Proactively identifies, resolves/mitigates through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.

• Monitors compliance metrics (i.e. regulatory, training, project timelines) and project budgets to ensure regulations and timelines are being met and activities performed are within the approved budget.

• Prepares project status report to client and ICON Pharmacovigilance Leadership.

• Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis and invoice approvals.

• Drives the on-time delivery of scope while actively managing change in scope requests and setting client and project team expectations.

• Ensures that project team resource allocations are in line with budget and to achieve deliverables.

• Proactively and timely identifies, negotiates and executes contract modifications for assigned projects.

• Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.

• Establishes project timelines for key milestones and deliverables and communicates project-specific priorities with the project team and monitors status for follow through.

To be successful in the role, you will have:

• 5 years + experience in pharmacovigilance at a global level in a client facing role.

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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