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Manager, Pharmacovigilance

0-1 years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

About the Role

Manager, Pharmacovigilance (Budgets & Proposals)
ICON plc is a leading healthcare intelligence and clinical research organization, committed to fostering an inclusive environment that drives innovation and excellence. We are currently seeking a Manager, Pharmacovigilance to join our dynamic team and oversee the pharmacovigilance activities within the company. This role is crucial to ensuring the safety and efficacy of clinical trial products and supporting the successful lifecycle management of drugs.


Key Responsibilities

  • Leadership of Pharmacovigilance Team: Lead a team focused on the collection, evaluation, and reporting of adverse events, ensuring full compliance with regulatory guidelines and internal standards.

  • Process and Policy Development: Develop and implement processes and policies that optimize the efficiency and effectiveness of safety monitoring activities.

  • Collaboration Across Functions: Work closely with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.

  • Training and Guidance: Provide training and expert guidance to team members and stakeholders on pharmacovigilance regulations, practices, and procedures.

  • Safety Monitoring and Analysis: Monitor and analyze safety data trends, assess risks, and present findings to relevant stakeholders.

  • Regulatory Compliance: Ensure that all pharmacovigilance activities adhere to global regulatory requirements and internal quality standards.


What You Need to Have

  • Bachelor’s degree in life sciences, pharmacy, or related field (advanced degrees are a plus).

  • Extensive experience in pharmacovigilance or drug safety management, with proven leadership experience.

  • Thorough knowledge of regulatory requirements and safety reporting standards.

  • Strong analytical skills, with the ability to assess safety data and prepare reports for regulatory submissions.

  • 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 stakeholders.

  • Detail-oriented, proactive, and committed to maintaining the highest standards of safety and quality.


What ICON Can Offer You

ICON offers a comprehensive benefits package designed to support your well-being and work-life balance:

  • Competitive salary and benefits tailored to your needs.

  • Annual leave entitlements, health insurance options, and retirement planning benefits.

  • Global Employee Assistance Program (LifeWorks), offering access to specialized professionals for your well-being.

  • Life assurance and other flexible country-specific benefits, including childcare vouchers, gym memberships, travel passes, and health assessments.


Why ICON?

At ICON, our success depends on the quality of our people. That’s why we focus on creating a diverse, high-performance culture that nurtures talent. Diversity, inclusion, and belonging are central to our values, and we believe a diverse workforce drives innovation and better service to our communities and clients. ICON is committed to a workplace free of discrimination and harassment, ensuring equal opportunity for all applicants.


How to Apply

If you’re interested in this role but unsure if you meet all the requirements, we encourage you to apply. You may be the perfect fit for ICON, and we’re excited to hear from you. If you are a current ICON employee, please click here to apply.a