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Drug Safety Associate
hace 3 meses
As a Drug Safety Associate you will be joining the world' s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
What you will be doing:
A Drug Safety Associate is a professional who is an integral part of drug development lifecycles to collect accurate safety information and to ensure patient safety.- 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.
- All employees must read, write and speak fluent English and host country language.
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.
In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people.That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
