Senior Manager, Pharmacovigilance

5+ years

Not Disclosed

Remote - Europe

10 Oct. 7, 2024

Job Description

Job Type: 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

Senior Manager, Pharmacovigilance

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

At ICON, we provide comprehensive outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations, advancing clinical research from molecule to medicine. With patients at the center of everything we do, we accelerate the development of drugs and devices that save lives and enhance quality of life. Our people are our greatest asset, embodying our culture and driving our success. ICON team members are committed to achieving excellence and ensuring high-quality outcomes.

Description:

Monitor projects to ensure profitability and achievement of goals.
Serve as the main point of contact for customers throughout the lifecycle of assigned projects and programs, and as the primary pharmacovigilance contact for full-service projects.
Develop, implement, and monitor profitability metrics and objectives for direct reports.
Identify and recommend process improvements within service areas based on project reviews.
Manage resources and projections to align project teams with client needs and contractual obligations.
Analyze current and future project backlogs to allocate adequate resources for business objectives.
Implement process improvements to enhance efficiencies.
Provide technical oversight for project plans, including Safety Management Plans (SMP) and SAE Reconciliation plans, during the setup phase.
Deliver training on department-related topics and company processes to pharmacovigilance staff.
Collaborate with other functional managers to ensure consistency in pharmacovigilance approaches across the company.
Stay updated on industry practices and regulatory requirements affecting service areas.
Review project tasks for Pharmacovigilance Associates, Specialists, and Assistants; lead service delivery to clients.
Support direct reports in identifying out-of-scope activities and implementing process improvements or contract amendments as needed.
Ensure staff compliance with company and client QMS, policies, procedures, and SOPs.
Foster an environment that promotes learning, self-improvement, and career development.
Review SOPs and processes to identify improvement opportunities and recommend plans to senior management.
Enhance teamwork and productivity across functional areas.
Provide mentorship and performance feedback for staff development.
Participate in recruiting processes for new employees within the service area.
Assist in bringing new business opportunities and maintaining client relationships for repeat business.
Engage with clients and participate in meetings to support new business initiatives.
Contribute to business development efforts, including presentations and proposal development.
Ensure timely and accurate submissions for all proposal efforts.
Support direct reports and senior management during audit preparations and respond to findings as needed.
Coordinate interdepartmental activities, including quality control processes and audits.
Act as a Subject Matter Expert (SME) for various technologies and processes.
Develop and deliver training on pharmacovigilance topics for ICON employees and external parties (e.g., investigators, clients).
Establish an industry presence through writing articles, presenting at conferences, and obtaining certifications.
Represent the pharmacovigilance service area in global initiatives, making autonomous decisions with minimal supervision.

Requirements:

In-depth knowledge of local and global medical device regulations, guidelines, policies, and ICH Guidelines.
Strong project management skills.
Ability to make independent decisions and operate autonomously.
Excellent planning, organization, people management, time management, and change management skills.
Strong client relationship skills; experience in client interactions is advantageous.
Highly motivated and proactive.
Ability to organize teams for stable and scalable structures.

Benefits of Working at ICON:

Our success relies on the quality and capabilities of our people. We are committed to fostering a continuous learning culture that challenges you with engaging work and supports your professional development.

In addition to a competitive salary, ICON offers a comprehensive total rewards package, including:

Various annual leave entitlements.
A range of health insurance options tailored to you and your family’s needs.
Competitive retirement planning offerings to help you save for the future.
Global Employee Assistance Program, LifeWorks, providing 24/7 access to over 80,000 professionals for well-being support.
Life assurance.
Flexible country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments.

Visit our careers site to explore more about the benefits ICON offers.

ICON is an equal opportunity and inclusive employer, dedicated to providing a workplace free from 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 protected veteran status.

If you require reasonable accommodations due to a medical condition or disability during the application process or in performing the essential functions of the position, please let us know.

Interested in the role but unsure if you meet all requirements? We encourage you to apply regardless—there’s a good chance you’re exactly what we’re looking for at ICON, whether for this position or others.

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