Senior Pharmacovigilance Project Manager

3 weeks ago

Melbourne, Victoria, Australia Pharmiweb Full time
Job Title: Senior Pharmacovigilance Project Manager

At ICON plc, we are seeking a highly skilled Senior Pharmacovigilance Project Manager to join our team. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the successful delivery of projects within the Pharmacovigilance function.

Key Responsibilities:
  • Ensure that Standard Operating Procedures (SOPs), policies, and guidelines are adhered to at the project level, and assign project-specific training to the project team.
  • Act as the primary liaison for clients and project teams for project-level matters, including time, scope, cost, quality, and resource management.
  • Manage and deliver assigned projects per fully executed contracts, on schedule, and on budget.
  • Lead and direct cross-functional team leads/managers and third parties/vendors with some supervision and support, ensuring the team is familiar with client and project scope.
  • Develop and manage the Project Management Plan throughout the lifecycle of the project.
  • Contribute to the development, maintenance, and approval of project plans.
  • Guide and support 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.
  • Lead and facilitate client and internal project meetings and be responsible for approving meeting agendas and minutes, ensuring inclusion of applicable topics, actions, and action item follow-up.
  • Liaise with functional leads/managers to optimize performance and utilization and manage feedback of project team members.
  • Lead the presentation of internal project status reviews (Pharmacovigilance Project Review or Finance Meetings) and be accountable for content development and action item follow-up.
  • Proactively identify, resolve/mitigate through ongoing review of project progress and metrics, and escalate risks and/or issues until resolution.
  • Monitor 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.
  • Prepare project status reports to clients and ICON Pharmacovigilance Leadership.
  • Own projections of units/hours (revenue and resources), actual units/hours efficiency analysis, and invoice approvals.
  • Drive the on-time delivery of scope while actively managing change in scope requests and setting client and project team expectations.
  • Ensure that project team resource allocations are in line with budget and to achieve deliverables.
  • Proactively and timely identify, negotiate, and execute contract modifications for assigned projects.
  • Identify potential or actual unrecoverable hours and provide analysis and mitigation/resolution plan for senior management's approval.
  • Establish project timelines for key milestones and deliverables and communicate project-specific priorities with the project team and monitor status for follow-through.
Requirements:
  • 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 of experience in pharmacovigilance at a global level in a client-facing role.
  • A degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
What ICON Can Offer:

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, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a global Employee Assistance Programme.

At ICON, we are 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 you are interested in this role but unsure if you meet all the requirements, we encourage you to apply. We would be happy to discuss this opportunity further with you.

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