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Senior Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Jan. 13, 2025
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 Manager, Pharmacovigilance (Budgets & Proposals)

About ICON plc:

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re dedicated to fostering an inclusive environment that drives innovation and excellence. Join us in shaping the future of clinical development, advancing patient safety, and contributing to the progress of global healthcare.

We are seeking a Senior Manager, Pharmacovigilance (Budgets & Proposals) to join our dynamic and growing team. As part of ICON’s Pharmacovigilance team, you will play a crucial role in managing pharmacovigilance activities, ensuring the safety and efficacy of clinical trial products throughout their lifecycle, and maintaining compliance with regulatory requirements.

What You Will Be Doing:

  • Leadership: Lead and manage the pharmacovigilance team in the collection, evaluation, and reporting of adverse events, ensuring adherence to regulatory guidelines and internal standards.
  • Process Development: Create and implement pharmacovigilance processes and policies to improve safety monitoring activities and enhance efficiency.
  • Cross-Functional Collaboration: Collaborate with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.
  • Training and Guidance: Provide training and guidance to team members and stakeholders on pharmacovigilance regulations and best practices.
  • Safety Monitoring: Monitor and analyze safety data trends, prepare risk assessments, and present findings to relevant stakeholders.
  • Regulatory Compliance: Ensure all pharmacovigilance activities meet global regulatory requirements and internal quality standards.

Your Profile:

  • Qualifications: A Bachelor’s degree in life sciences, pharmacy, or a related field is preferred, with extensive experience in pharmacovigilance or drug safety management.
  • Experience: Proven leadership in managing pharmacovigilance teams, with a deep understanding of regulatory requirements and safety reporting standards.
  • Skills:
    • Strong analytical skills for assessing safety data and preparing safety reports.
    • Exceptional leadership and organizational skills, with the ability to manage multiple projects in a fast-paced environment.
    • Effective communication and interpersonal skills to collaborate across teams and with external stakeholders.
  • Attributes: Detail-oriented, proactive, and committed to upholding high standards of safety and quality in all pharmacovigilance operations.

What ICON Can Offer You:

ICON’s success depends on the quality of its people. We offer a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, we provide a range of benefits that support well-being and work-life balance, including:

  • Annual Leave: Generous paid time off.
  • Health Insurance: A variety of health insurance options for you and your family.
  • Retirement Planning: Competitive retirement options to help you plan for the future.
  • Employee Assistance Program: Access to a global network of professionals who provide support 24/7.
  • Life Assurance: Coverage to protect you and your family.
  • Flexible Benefits: Optional benefits such as childcare vouchers, gym memberships, travel passes, and more.

Diversity, Inclusion, and Belonging at ICON:

Diversity and inclusion are integral to our culture at ICON. We are committed to providing an inclusive and accessible environment for all candidates. ICON is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Reasonable Accommodation:

If you need a reasonable accommodation to participate in the application process or perform the essential functions of the role due to a medical condition or disability, please let us know.

Interested in the Role?

Even if you don’t meet every requirement, we encourage you to apply—we may still be looking for someone like you to make a significant impact at ICON.

Current ICON Employees: If you’re already a part of ICON, please click here to apply.