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Proposals Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Jan. 21, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm and LifeScience Graduates 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: Proposals Manager, Pharmacovigilance

Company: ICON plc

About ICON: ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence. Join us on our mission to shape the future of clinical development.

Position Overview: We are currently seeking a Proposals Manager to join our diverse and dynamic Pharmacovigilance (PV) team. This senior individual contributor role is responsible for overseeing various pharmacovigilance activities, primarily focusing on creating proposals and budgets, ensuring the safety and efficacy of clinical trial products throughout their lifecycle, ensuring compliance with regulatory requirements, and fostering a culture of safety and quality within our organization.


What You Will Be Doing:

  • Support the ongoing growth of the PV team, primarily as an individual contributor.
  • Create budgets and proposals for PV standalone projects.
  • Conduct QPPV (Qualified Person for Pharmacovigilance) activities, literature reviews, and provide local PV support.
  • Develop and implement pharmacovigilance processes and policies to enhance the efficiency and effectiveness of safety monitoring activities.
  • Collaborate with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.
  • Provide training and guidance to team members and stakeholders on pharmacovigilance regulations, practices, and procedures.
  • Monitor and analyze safety data trends, prepare risk assessments, and present findings to relevant stakeholders.
  • Ensure that all pharmacovigilance activities comply with global regulatory requirements and internal quality standards.

Your Profile:

  • Education: Bachelor’s degree in life sciences, pharmacy, or a related field is preferred.
  • Experience: Extensive experience in pharmacovigilance or drug safety management.
  • Skills & Knowledge:
    • A passion for PV with broad knowledge and comfort in a standalone role.
    • Proven experience in managing pharmacovigilance teams and activities, with a thorough understanding of regulatory requirements and safety reporting standards.
    • Experience in creating budgets and proposals and conducting literature reviews.
    • Strong analytical skills, with experience in assessing safety data and preparing safety reports for regulatory submission.
    • Excellent leadership and organizational skills, with the ability to manage multiple projects in a fast-paced environment.
    • Exceptional communication and interpersonal skills to collaborate effectively with cross-functional teams and external stakeholders.
    • Detail-oriented, proactive, and committed to maintaining high standards of safety and quality in pharmacovigilance operations.

What ICON can offer you:

At ICON, our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. These benefits are designed to be competitive within each country and focus on well-being and work-life balance opportunities for you and your family.

Benefits Include:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning options to help you save for the future.
  • Global Employee Assistance Programme (LifeWorks) offering 24-hour access to a network of over 80,000 independent professionals who can support your well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.

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


Diversity, Inclusion & Belonging:

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We celebrate our diverse workforce and the work we’ve done to become a more inclusive organization. We are dedicated to providing an accessible environment for all candidates.

Equal Opportunity Employment: ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


Accommodation Request:

If you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of the position due to a medical condition or disability, please let us know.


Interested in the Role?

If you’re unsure whether you meet all of the requirements, we encourage you to apply anyway. There’s every chance you’re exactly what we’re looking for at ICON, whether it’s for this or other roles.


Apply Today!