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Pharmacovigilance Reporting Associate
Pharmacovigilance Reporting Associate-March 2024
Osaka
Mar 28, 2026
About Pharmacovigilance Reporting Associate

  At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

  Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

  That’s our vision. We’re driven by it. And we need talented people who share it.

  If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

  Role & Responsibilities :

  Serve as safety reporting processor or lead for multiple safety reporting, providing management support as designated.

  Recognize, exemplify, and adhere to ICON's values, which center around our commitment to People, Clients, and Performance.

  As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and client processes.

  Responsible for safety reporting or safety reporting intelligence activities on assigned projects, working in a customer focused approach and an audit and inspection ready mindset.

  Demonstrate skills pertaining to client management, safety reporting, project scope, submission compliance, quality, and budget.

  The following safety information case processing tasks related to clinical trials/post-marketing of pharmaceutical products

  Receipt of information on Adverse event, triage, numbering, confirmation of details, entry into database/QC

  Creation of explanatory text for case course (Japanese and English)/QC

  Primary evaluation of the necessity of reporting to the PMDA / QC of the evaluation details

  Preparation of reports to PMDA/QC

  Escalation, coordination, etc. to customers

  Operations incidental to the above

  *Our Safety Reporting team will allow you to experience the ICCC study start-up, not just safety reporting. At first, senior members will support you. You could expand your experience.

  Requirements:

  Experience required for ①or②

  ①PV experience, especially PMDA submission experience required. Experience with ICCC is better.

  ②2+ years of CRA experience

  Fluency in Japanese, business level English

  Benefits of Working in ICON:

  Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

  We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

  We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

  But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

  ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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