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Pharmacovigilance Associate

2+ years
Not Disclosed
10 Sept. 7, 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: Pharmacovigilance Associate

Location: Tokyo, Japan

About ICON plc: ICON plc is a leading global healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

At ICON, our employees set us apart. Through diverse teams, we enhance our client partnerships and advance patient care. Our "Own It" culture unites us as individuals and differentiates us as an organization, guided by four key values: accountability, collaboration, partnership, and integrity. We aim to be the partner of choice in pharmaceutical development, providing excellence at every client and patient interaction.

Role Overview: We are seeking a Pharmacovigilance Associate to join our dynamic and diverse team. In this role, you will be crucial in ensuring drug safety and efficacy, monitoring adverse events, and contributing to the overall quality and compliance of pharmacovigilance activities.

Key Responsibilities:

  • Collect, process, and evaluate adverse event reports from various sources including healthcare professionals, clinical trial sites, and regulatory authorities.
  • Perform case processing activities such as data entry, medical coding, and signal detection in accordance with established procedures and regulatory requirements.
  • Assist in the preparation of regular safety reports, risk management plans, and other pharmacovigilance documentation.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and medical writing, to ensure timely and accurate safety information reporting.
  • Participate in the continuous improvement of pharmacovigilance processes, systems, and standard operating procedures.

What We’re Looking For:

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
  • Experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry.
  • In-depth knowledge of pharmacovigilance regulations, guidelines, and industry best practices.
  • Proficiency in handling adverse event reporting databases and safety management systems.
  • Strong attention to detail with the ability to accurately interpret and document safety information.
  • Excellent written and verbal communication skills, with the ability to work effectively in a cross-functional team environment.

What ICON Offers: Our success is driven by the quality of our people. We prioritize creating a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON provides a range of benefits, including:

  • Various annual leave entitlements
  • Health insurance options to meet your and your family’s needs
  • Competitive retirement planning offerings to help you save and plan for the future
  • Global Employee Assistance Program, LifeWorks, offering 24-hour access to a global network of professionals for support
  • Life assurance
  • Flexible benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments

For more details on the benefits ICON offers, visit our careers site.

Equal Opportunity Statement: ICON is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require a reasonable accommodation due to a medical condition or disability for any part of the application process or to perform the essential functions of the position, please let us know or submit a request here.

Interested in the Role? If you’re interested in this role but are unsure if you meet all the requirements, we encourage you to apply. You might be exactly what we’re looking for, whether for this role or others at ICON.

Current ICON Employees: Please click here to apply.