Senior Pharmacovigilance Project Manager

5+ years

Not Disclosed

Remote, USA

10 Oct. 9, 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

Senior Pharmacovigilance Project Manager

Company Overview: ICON plc is a leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment that drives innovation and excellence. We invite you to join us on our mission to shape the future of clinical development.

Role Overview: As a Senior Pharmacovigilance Project Manager, you will ensure adherence to Standard Operating Procedures (SOPs), policies, and guidelines at the project level. You will be the primary liaison for clients and the project team, overseeing project timelines, scope, budget, and quality.

Key Responsibilities:

Ensure project teams receive project-specific training and understand the client’s expectations.
Manage and deliver assigned projects on schedule and within budget, in line with the fully executed contract.
Lead cross-functional teams and third-party vendors, providing guidance and support.
Develop and manage the Project Management Plan throughout the project lifecycle.
Contribute to the development, maintenance, and approval of project plans.
Support project team leads in prioritization, troubleshooting, and contingency planning.
Monitor project progress, deadlines, and milestones to ensure timely completion.
Facilitate client and internal project meetings, approving agendas and minutes.
Liaise with functional leads to optimize team performance and address feedback.
Present internal project status reviews and ensure follow-up on action items.
Identify and mitigate project risks proactively, escalating issues as needed.
Monitor compliance metrics and project budgets, ensuring alignment with regulations.
Prepare project status reports for clients and ICON leadership.
Manage resource allocations to meet project deliverables while adhering to budget.
Negotiate and execute contract modifications when necessary.
Establish timelines for key milestones and communicate priorities to the project team.

Qualifications:

Extensive experience in pharmacovigilance, particularly in safety reporting within clinical trials.
Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
5+ years of experience in a global pharmacovigilance role, ideally in a client-facing capacity.
Degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.

What We Offer: At ICON, our success hinges on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a comprehensive benefits package, including:

Various annual leave entitlements.
Health insurance options tailored to you and your family’s needs.
Competitive retirement planning offerings.
Global Employee Assistance Programme, providing 24/7 support for your well-being.
Life assurance and flexible optional benefits (e.g., childcare vouchers, gym memberships).

Explore more about our benefits on our careers site.

Commitment to Diversity: ICON is an equal opportunity employer dedicated to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you require reasonable accommodations during the application process or to perform essential functions of the role, please let us know.

Interested in the Role? If you’re intrigued by this opportunity but aren’t sure you meet all the qualifications, we encourage you to apply. You might be exactly what we’re looking for at ICON!

Current ICON Employees: If you are a current ICON employee, please click here to apply.

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Senior Pharmacovigilance Project Manager

Job Description

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