Senior Pharmacovigilance Project Manager

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Pharmacovigilance Project Manager – Remote (Blue Bell, PA)
Location: Remote (U.S.)
Company: ICON plc

About ICON plc

ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to helping pharmaceutical, biotechnology, medical device, and public health organizations advance clinical research from molecule to medicine. At ICON, we place patients at the center of everything we do, accelerating the development of drugs and devices that save lives and improve the quality of life. We are committed to innovation, excellence, and inclusivity, and we invite you to join our mission to shape the future of clinical development.

Position Overview

We are seeking a Senior Pharmacovigilance Project Manager to lead and manage pharmacovigilance projects that may range from simple to complex, across different functional areas and business units. In this role, you will provide valuable insight into project impacts, ensuring that projects meet the highest standards of quality, compliance, and performance. You will serve as the primary point of contact for clients and lead cross-functional teams to deliver projects on time and within budget.

This position is fully remote within the United States, with the flexibility to work from home.

Key Responsibilities

Customer Contact & Leadership

Act as the primary project manager for a portfolio of Pharmacovigilance projects, managing expectations and ensuring that timelines, scope, and quality are met.
Lead and mentor the project team, ensuring successful delivery of all project milestones and objectives.
Serve as the liaison between the client and the project team, managing communication around time, cost, quality, and resources.
Lead cross-functional teams, including vendors and third parties, while collaborating with functional leads to optimize performance.
Manage regulatory compliance, training, and budgetary requirements across all projects.
Define success criteria, manage communications, and track deliverables for complex projects.

Communication & Stakeholder Engagement

Lead internal and client-facing meetings, ensuring agendas and minutes are approved.
Present project status updates during internal reviews and financial meetings.
Serve as a subject matter expert (SME) for pharmacovigilance proposals, including leading the bid defense process.
Contribute to the development of practices and tools that drive continuous process improvements.
Stay current on industry technologies, best practices, and emerging trends to inform project strategies and decisions.

Project Delivery

Manage the project lifecycle, ensuring the timely and on-budget delivery of projects as per the contract.
Develop and manage the Project Management Plan throughout the project phases, ensuring effective prioritization and task management.
Oversee project plans, troubleshoot issues, and develop contingency strategies to maintain high-quality project execution.
Prepare and deliver status reports to clients and senior leadership teams.

Finance & Budget Management

Oversee project budgets, resource allocation, and invoice approvals to ensure financial management is on track.
Negotiate contract modifications and oversee the execution of those changes.
Conduct detailed analysis of project timelines and financials for senior management and clients to ensure successful project outcomes.

Qualifications & Skills

To be successful in this role, you will have:

A minimum of 6 years of experience in pharmacovigilance project management within a CRO or pharmaceutical company.
Bachelor's degree in a relevant field.
Strong leadership and communication skills, with a proven ability to manage cross-functional teams.
Extensive experience managing pharmacovigilance projects, including project delivery, client interaction, and financial management.
Deep knowledge of regulatory requirements and industry standards related to pharmacovigilance and clinical development.
The ability to think strategically and solve complex problems, ensuring timely project delivery.
Familiarity with industry technologies, tools, and methods for process improvements.

What ICON Offers You

At ICON, we believe our people are our greatest asset. We are committed to providing a competitive total rewards package that supports your career development, work-life balance, and well-being. This includes:

Comprehensive health insurance options for you and your family.
Retirement planning and competitive savings programs.
Generous annual leave entitlements and work flexibility.
Employee Assistance Program (EAP), offering global 24/7 support for mental health and well-being.
Life assurance and a range of optional benefits such as childcare vouchers, gym memberships, health assessments, and more.

Why ICON?

At ICON, we are passionate about advancing clinical research and making a real difference in people’s lives. We are committed to building a diverse and inclusive workforce, where everyone has the opportunity to grow, contribute, and succeed. Our culture fosters innovation, collaboration, and continuous learning.

ICON plc is an Equal Opportunity Employer
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 need reasonable accommodation to apply or perform the essential functions of this role, please submit a request.

Application Instructions

If you’re interested in this role and feel that you meet the qualifications, we encourage you to apply! If you are a current ICON employee, please click here to apply directly.