Drug Safety Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Receives and processes individual case safety reports ((ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports. This includes: Tracking of received ICSR, entry of ICSR into company or client safety database and query management.
• Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety Database.
• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement.
• Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
• Supports interim data analysis for DMC reviews.
• Receives inquiries from consumers or healthcare professionals in support of marketed
  products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions

• You are:

  • • Bachelor’s degree in a health, life sciences or other relevant field of study.
    • The successful candidate will have relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
    • All employees must read, write and speak fluent English and host country language.

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/benefitsAt 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-accommodationsInterested 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.