Senior Manager, Pharmacovigilance

2+ years

Not Disclosed

Remote, USA

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote 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 Manager, Pharmacovigilance

Company: ICON plc

About ICON plc:
ICON plc is a world-leading healthcare intelligence and clinical research organization committed to advancing clinical development by providing outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. At ICON, patients are at the center of everything we do, and we are dedicated to accelerating the development of drugs and devices that save lives and improve quality of life. Our people are the cornerstone of our success, driving our mission with innovation and excellence.

Job Description:

As the Senior Manager, Pharmacovigilance at ICON plc, you will play a pivotal role in overseeing the pharmacovigilance operations of multiple projects. You will ensure that the company’s profitability and project goals are met while serving as the primary point of contact for customers across stand-alone and full-service projects. Your role will include resource management, process improvement, and providing leadership to a team of direct reports within pharmacovigilance.

Key Responsibilities:

Project Monitoring: Ensure projects meet profitability and objective goals while maintaining high client satisfaction.
Client Interaction: Serve as the primary point of contact for customers throughout the lifecycle of assigned projects.
Team Leadership: Develop, implement, and monitor goals and metrics for the pharmacovigilance team, ensuring efficient project execution.
Resource Management: Oversee resource allocation, managing projections and ensuring alignment with client needs and project requirements.
Process Improvement: Identify areas for improvement and implement solutions to enhance efficiencies within the service area.
Regulatory Oversight: Provide technical oversight on the development of project plans, such as Safety Management Plans (SMP) and SAE Reconciliation Plans.
Training & Development: Deliver training on pharmacovigilance processes to staff and collaborate across functional areas to ensure consistency.
Staff Mentorship: Create an environment of learning and self-improvement, providing feedback and supporting career development initiatives.
Client Relationships: Engage with clients to support business development, client retention, and new business opportunities.
Audit Support: Assist during audits and compliance reviews, responding to findings and ensuring corrective actions are taken.

Required Skills & Qualifications:

Knowledge: In-depth understanding of local and global medical device Health Authority regulations, ICH Guidelines, and pharmacovigilance practices.
Project Management: Proven ability to manage complex projects and deliver results.
Leadership: Strong leadership and people management skills, with the ability to operate independently and autonomously.
Communication: Effective communication skills with the ability to foster strong relationships with clients and internal teams.
Proactive & Motivated: Self-starter with a highly proactive mindset to drive process improvements and resource management.

Benefits at ICON:

ICON offers a comprehensive and competitive rewards package, including:

Annual leave entitlements and flexible work-life balance options
Health insurance options tailored to individual and family needs
Competitive retirement planning programs
Global Employee Assistance Program (LifeWorks) for personal well-being
Life assurance and optional benefits like childcare vouchers and gym memberships

At ICON, we believe in the power of diversity and inclusion to drive innovation and deliver high-quality services. We are committed to building an inclusive workforce where everyone has an opportunity to succeed.

Equal Opportunity:

ICON plc is an equal opportunity employer and embraces diversity in all forms. We are committed to providing an inclusive and accessible environment for all candidates and employees. We encourage individuals from all backgrounds to apply, regardless of race, religion, gender, age, or disability status.

Application Process:

If you are excited about the opportunity to make an impact in the world of clinical development and pharmacovigilance, we encourage you to apply today.

If you are an ICON employee, please apply through the internal portal.

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Senior Manager, Pharmacovigilance

Job Description

Job Description:

Key Responsibilities:

Required Skills & Qualifications:

Benefits at ICON:

Equal Opportunity:

Application Process:

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