Pharmacovigilance Associate

As a (Pharmacovigilance Associate) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Ensures submission of expedited and periodic safety reports to Regulatory
  Authority according to local regulations, for clinical trials and post-marketing setting in Korea
• Manages collection, processing, follow-up, transmission, and documentation of PV cases from post-marketing setting in Korea (spontaneous reports, literature, post- marketing study/program, post-authorisation studies etc.), in accordance with company procedures and regulations
• Manages health authority cases for product renewal, and case entry into safety database
• Monitors compliance for PV activities and implements CAPA (Corrective and Preventive Actions) when applicable.
• Conducts local literature review on a weekly basis to detect PV case and reports according to internal procedures
• Ensures tracking, filing and archiving of PV documentation
• Performs monthly reconciliation with other functions (eg. quality complaints / medical information enquiries) for potential AEs, and also with other third parties to ensure all cases have been transmitted.
• Performs reconciliation with Global Safety to ensure all local cases are accurately collected into the global safety database.
• Participates in the implementation of RMP and activities in Korea when applicable, and collaborates with other departments involved in the RMP activities.
• Can perform other duties and responsibilities, as assigned

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You are:

• +1.5 yr PV Associate Experience in CRO/Pharma Indsutry
• Office Base (Partial Home-based)
• Good Competency in English

What ICON can offer you:

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.