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.

We have an incredible opportunity for a Pharmacovigilance Project Manager to join ICON Pharmacovigilance Project Oversight in our Pharmacovigilance, Safety Services, and Safety Reporting Group.

LOCATION:Mexico City, Mexico (office-based with remote flexibility)

OVERVIEW OF THE ROLE:

The Pharmacovigilance Project Manager (PM) leads assigned Pharmacovigilance projects through all phases of ICON’s project lifecycle to completeness, with a customer focused approach, and audit and inspection readiness 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.

• Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level
• Ensures assignment of project specific training to project team
• Act as 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
• Develops and manages 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
• Leads and facilitates client and internal project meetings and responsible to approve meeting agenda and minutes
• 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)
• 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
• Proactively and timely identifies, negotiates and executes contract modifications for assigned projects

TO BE SUCCESSFUL, YOU WILL NEED:

• 3-5 years of pharmacovigilance experience
• Project management experience including timeline, budget, and quality management
• Excellent written and oral communication skills
• Ability to read, write, and speak fluent English and host country language
• Understanding of the drug life cycle
• Strong time management skills and ability to prioritize
• Bachelor’s degree or local equivalent

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.

#LI-TCT1

#LI-HYBRID