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Proposals 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

Proposals Manager, Pharmacovigilance

About ICON plc:

ICON plc is a leading global healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment that drives innovation and excellence, and we invite you to join us in our mission to shape the future of clinical development.

We are currently seeking a Proposals Manager to join our diverse and dynamic Pharmacovigilance (PV) team. In this role, you will oversee various pharmacovigilance activities, with a primary focus on creating proposals and budgets. Your responsibilities will also include ensuring the safety and efficacy of clinical trial products throughout their lifecycle while ensuring compliance with regulatory requirements, fostering a culture of safety and quality within the organization.

What You Will Be Doing:

  • Lead PV Growth: Support the ongoing growth of the PV team in a senior capacity, acting as an individual contributor.
  • Proposal and Budget Creation: Develop proposals and budgets for PV standalone projects, ensuring alignment with client needs.
  • Safety and Efficacy Oversight: Manage activities related to QPPV, literature reviews, and local PV support.
  • Process Improvement: Develop and implement pharmacovigilance processes and policies to enhance the efficiency and effectiveness of safety monitoring activities.
  • Cross-Functional Collaboration: Work 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, practices, and procedures.
  • Risk Assessment and Reporting: Analyze safety data trends, prepare risk assessments, and present findings to stakeholders.
  • Regulatory Compliance: Ensure all pharmacovigilance activities are conducted in accordance with 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 significant experience in pharmacovigilance or drug safety management.
  • Experience: Proven experience in managing pharmacovigilance teams and activities, with a thorough understanding of regulatory requirements and safety reporting standards.
  • Skills:
    • Strong experience in creating proposals and budgets.
    • Proficient in literature reviews and safety data analysis.
    • Excellent leadership, organizational, and communication skills.
    • Ability to manage multiple projects and deliver results in a fast-paced environment.
  • Attributes: Detail-oriented, proactive, and committed to maintaining the highest standards in safety and quality.

What ICON Can Offer You:

ICON’s success is driven by the quality of its people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.

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

  • Annual Leave Entitlements: Generous paid time off.
  • Health Insurance: A range of offerings to suit you and your family’s needs.
  • Retirement Planning: Competitive retirement options to maximize savings.
  • Employee Assistance Program: Access to a global network of over 80,000 professionals for support.
  • Life Assurance: Coverage to protect you and your loved ones.
  • Flexible Benefits: Optional benefits like childcare vouchers, gym memberships, travel passes, and more.

Diversity, Inclusion, and Belonging at ICON:

At ICON, diversity and inclusion are integral to our culture. We are committed to providing a workplace free from discrimination and harassment and encourage individuals from all backgrounds to apply. We provide reasonable accommodations for candidates with disabilities or medical conditions.

Interested in the Role?

If you’re passionate about pharmacovigilance and want to make a meaningful impact in the clinical research industry, apply today. Even if you don’t meet every requirement, we encourage you to apply—we may still be looking for someone like you.

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