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Manager, Pharmacovigilance

2+ years
Not Disclosed
10 Sept. 27, 2024
Job Description
Job Type: Remote 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

About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development!

At ICON, our people are what set us apart. Our diverse teams enable us to better serve our customers and fulfill our mission to advance and improve patients' lives. Our ‘Own It’ culture is anchored by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aspire to be the Clinical Research Organization that delivers excellence to clients and patients at every touchpoint, making us the partner of choice in drug development.

Role Overview

We are currently seeking a Pharmacovigilance Manager to join our dynamic team. In this pivotal role, you will oversee safety reporting processes, ensure compliance with regulatory requirements, and safeguard patient safety through the monitoring and evaluation of adverse events in clinical trials.

Key Responsibilities

  • Manage the safety reporting process for clinical trials, ensuring timely and accurate submission of safety data to regulatory authorities.
  • Provide line management for a growing team of approximately five pharmacovigilance professionals across various global locations.
  • Collaborate with cross-functional teams to develop and implement safety management plans, ensuring adherence to global regulatory standards.
  • Analyze and interpret adverse event data to identify trends and provide strategic insights for risk mitigation.
  • Lead safety review meetings, contributing to the assessment and classification of safety signals and events.
  • Train and guide internal teams and external partners on safety reporting procedures and regulatory requirements.

Your Profile

  • Degree in life sciences, pharmacy, or a related field; advanced degree preferred.
  • Previous experience in line management, ideally with teams located in various global regions.
  • Strong background in pharmacovigilance, particularly in safety reporting within clinical trial settings.
  • In-depth knowledge of global regulatory requirements for safety reporting (e.g., FDA, EMA, ICH guidelines).
  • Experience navigating harmonization and restructuring during mergers or acquisitions is an asset.
  • Excellent analytical skills with the ability to interpret complex medical data and present findings clearly.
  • Proven leadership capabilities and experience in managing teams and collaborating with cross-functional stakeholders.

Benefits of Working at ICON

At ICON, our success hinges on the quality of our people. We prioritize building a culture that rewards high performance and nurtures talent. Here’s what we offer:

  • Competitive salary packages, regularly benchmarked against industry standards.
  • Annual bonuses that reflect performance goals—both organizational and individual.
  • Comprehensive health-related benefits for you and your family, alongside competitive retirement plans and life assurance.
  • An environment that encourages you to fulfill your sense of purpose and drive lasting change.

Commitment to Diversity

ICON is an equal opportunity employer, committed to providing a workplace free from discrimination and harassment. We welcome applicants from all backgrounds and ensure equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require accommodations during the application process or to perform essential job functions, please let us know.

Interested in the Role?

If you’re excited about this opportunity but unsure whether you meet all the requirements, we encourage you to apply. You may be exactly what we’re looking for, whether for this position or others.

Current ICON Employees: Please click here to apply.

Join us and help shape the future of clinical development!