Senior Pharmacovigilance Project Manager

Senior Pharmacovigilance Project Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Senior Pharmacovigilance Project Manager -

The role:

• 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.

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What you need:

To be successful in the role, you will have:

• Extensive experience in pharmacovigilance, particularly in safety reporting within a clinical trial setting.

• Strong knowledge of global regulatory requirements for safety reporting (e.g., FDA, EMA, ICH guidelines).•

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

• A degree in life sciences, pharmacy, or a related field; advanced degree preferred.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, colour, 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply