Proposals Manager, Pharmacovigilance

5+ years

Not Disclosed

Remote, USA

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 global leader in healthcare intelligence and clinical research, committed to shaping the future of clinical development. We are dedicated to fostering an inclusive environment that promotes innovation and excellence, and we invite you to join us in our mission to improve the lives of patients worldwide.

We are currently seeking a Proposals Manager to join our dynamic and growing Pharmacovigilance (PV) team. In this role, you will be responsible for creating proposals and budgets for PV projects, ensuring the safety and efficacy of clinical trial products throughout their lifecycle, and ensuring compliance with regulatory requirements.

What You Will Be Doing:

Lead PV Growth: Support the ongoing growth of the PV team, acting as a senior individual contributor.
Proposal and Budget Creation: Develop proposals and budgets for standalone pharmacovigilance 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 safety monitoring efficiency.
Cross-Functional Collaboration: Work with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting.
Training and Guidance: Provide training to team members and stakeholders on pharmacovigilance regulations and practices.
Risk Assessment and Reporting: Analyze safety data trends, prepare risk assessments, and present findings to 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 significant experience in pharmacovigilance or drug safety management.
Experience: Proven experience managing pharmacovigilance teams and activities, with an in-depth understanding of regulatory requirements and safety reporting standards.
Skills:
- Strong background in creating proposals and budgets.
- Proficient in literature review and safety data analysis.
- Excellent leadership, organizational, and communication skills.
- Ability to manage multiple projects and deliver results in a fast-paced environment.
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.

By joining ICON, you’ll help shape the future of clinical research and improve patient safety through cutting-edge pharmacovigilance practices.

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Proposals Manager, Pharmacovigilance

Job Description

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