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Senior Manager, Pharmacovigilance

2+ years
Not Disclosed
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

Senior Manager, Pharmacovigilance - ICON plc

About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re driven by innovation, excellence, and an inclusive culture, and we invite you to join us on our mission to shape the future of clinical development. From molecule to medicine, we provide outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. With a patient-centered approach, we accelerate the development of drugs and devices that save lives and improve quality of life. At ICON, our people are our greatest strength and at the core of our success.

Role Overview:
As a Senior Manager in Pharmacovigilance, you will be responsible for overseeing project management to ensure profitability and the achievement of project goals. This role involves managing resources, improving processes, and ensuring compliance with regulatory guidelines. You will serve as the main point of contact for assigned projects, work closely with clients, and ensure the quality of service delivery.

Key Responsibilities:

  • Monitor projects to ensure profitability and that project goals and objectives are met.
  • Serve as the main pharmacovigilance point of contact for assigned projects and programs.
  • Develop and monitor the profitability, objectives, and metrics of the assigned group of direct reports.
  • Manage resources and project team requirements, ensuring that teams align with client needs, expectations, and contractual obligations.
  • Identify and implement process improvements and efficiency strategies.
  • Provide technical oversight on project plans (e.g., Safety Management Plans, SAE Reconciliation plans) and collaborate with the project team during setup.
  • Deliver training on pharmacovigilance topics and processes to staff.
  • Maintain knowledge of current industry practices and regulatory requirements impacting pharmacovigilance services.
  • Ensure that services comply with company policies, SOPs, and quality management standards.
  • Support staff development through mentorship and career guidance.
  • Involved in recruiting, business development, client meetings, and proposal development.
  • Support audit preparation and conduct, ensuring compliance with industry standards.

Key Requirements:

  • Thorough knowledge of local and global medical device Health Authority regulations, guidelines, and ICH Guidelines.
  • Strong project management skills with the ability to operate independently and make decisions autonomously.
  • Excellent organizational, people, and change management skills.
  • Ability to maintain strong relationships with clients and lead cross-functional teams.
  • Highly motivated and proactive, with a focus on continuous process improvement.

What ICON Offers: ICON recognizes the value of our people and is committed to fostering a diverse culture that promotes innovation and high performance. We offer a comprehensive and competitive total reward package, including:

  • Annual leave entitlements and health insurance offerings for you and your family.
  • Competitive retirement planning options.
  • Life assurance and flexible, country-specific benefits.
  • Employee Assistance Programme (LifeWorks) offering 24/7 support to you and your family.
  • Work-life balance initiatives, including flexible working policies and wellbeing programs.

Diversity and Inclusion: At ICON, we believe that diversity, inclusion, and belonging are fundamental to our culture. Our workforce reflects the communities we serve, and we are proud of our efforts to foster a more inclusive organization. We’re committed to providing an environment free from discrimination and harassment, offering equal opportunities for all applicants.

Interested?
If this role excites you, we encourage you to apply even if you don't meet all the listed requirements. We value diverse experiences and skill sets, and there's a strong chance you could be exactly what we’re looking for.

Apply now at ICON Careers

Equal Opportunity Employer
ICON is an equal opportunity employer. We ensure fair treatment for all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We provide reasonable accommodations for applicants with disabilities.