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Manager, Pharmacovigilance

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

About the Role:
ICON plc, a world-leading healthcare intelligence and clinical research organization, is looking for a Manager, Pharmacovigilance to join our diverse and dynamic team. In this role, you will oversee pharmacovigilance activities to ensure the safety and efficacy of clinical trial products throughout their lifecycle. This includes managing a dedicated team, ensuring compliance with regulatory requirements, and fostering a culture of safety and quality within the organization.

What You Will Be Doing:

  • Lead the pharmacovigilance team in the collection, evaluation, and reporting of adverse events, ensuring compliance with regulatory guidelines and internal standards.
  • Develop and implement pharmacovigilance processes and policies to enhance the efficiency and effectiveness of safety monitoring activities.
  • Collaborate with clinical, regulatory, and quality assurance teams to ensure comprehensive safety assessments and timely reporting of safety data.
  • Provide training and guidance to team members and stakeholders on pharmacovigilance regulations, practices, and procedures.
  • Monitor and analyze safety data trends, preparing risk assessments, and presenting findings to relevant stakeholders.
  • Ensure that all pharmacovigilance activities are conducted in accordance with global regulatory requirements and internal quality standards.

Your Profile:

  • Bachelor’s degree in life sciences, pharmacy, or a related field (preferred).
  • Extensive experience in pharmacovigilance or drug safety management.
  • Proven experience in managing pharmacovigilance teams and activities, with a thorough understanding of regulatory requirements and safety reporting standards.
  • Strong analytical skills, with experience in assessing safety data and preparing safety reports for regulatory submission.
  • Excellent leadership and organizational skills, with the ability to manage multiple projects in a fast-paced environment.
  • Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
  • Detail-oriented, proactive, and committed to maintaining the highest standards of safety and quality in pharmacovigilance operations.

What ICON Can Offer You:
At ICON, we understand the importance of a high-quality workforce and are committed to building a diverse culture that rewards high performance and nurtures talent. We offer a competitive salary and a range of benefits designed to prioritize well-being and work-life balance, including:

  • Various annual leave entitlements
  • A range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme (LifeWorks)
  • Life assurance
  • Flexible country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and more.

ICON’s Commitment to Diversity:
ICON embraces diversity, inclusion, and belonging as core values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and communities. We are dedicated to providing an inclusive and accessible environment for all candidates. ICON is an equal opportunity employer and is committed to ensuring a workplace free from discrimination and harassment.