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Pharmacovigilance Manager

5+ years
Not Disclosed
10 Dec. 17, 2024
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

Job Title: Manager, Pharmacovigilance
Company: ICON plc

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

Position Overview: We are seeking a Manager, Pharmacovigilance to join our dynamic and diverse team. This role is pivotal in overseeing various pharmacovigilance activities, 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.

Key Responsibilities:

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

Qualifications:

  • Bachelor’s degree in life sciences, pharmacy, or related field preferred.
  • Extensive experience in pharmacovigilance or drug safety management.
  • Passion for PV with the ability to work comfortably in a standalone role.
  • Proven experience in managing PV teams and activities, with a thorough understanding of regulatory requirements.
  • Experience in creating budgets, proposals, and conducting literature reviews.
  • Strong analytical skills with experience in assessing safety data and preparing regulatory safety reports.
  • Exceptional leadership, organizational, and project management skills.
  • Excellent communication and interpersonal skills with the ability to collaborate effectively.
  • Detail-oriented, proactive, and committed to maintaining high safety and quality standards in PV operations.

What ICON Can Offer You:

  • Competitive salary and benefits packages, including health insurance, retirement planning, and more.
  • Flexible work-life balance opportunities.
  • Access to global Employee Assistance Program (LifeWorks).
  • Various country-specific optional benefits (childcare vouchers, bike schemes, discounted gym memberships, and more).

Diversity and Inclusion at ICON: ICON is committed to creating an inclusive environment and values the diversity of our workforce. We ensure equal opportunities for all applicants regardless of race, gender, disability, or any other characteristic. If you need reasonable accommodations during the application process, please let us know.

Interested? Apply Now! We encourage you to apply even if you’re unsure you meet all the requirements. You may be exactly what we’re looking for at ICON.