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:

1. Perform initial review of the adverse event perform seriousness and relatedness assessment and follow up SAE/AE/ADR/SADR queries to investigator sites or reporter(s)
2. Liaise with the investigational site and or reporter regarding safety issue.
3. Ensure accurate entry of safety data into the safety database or relevant system.
4. May assist the team in create patient adverse event narratives, if appropriate
Archive document related to entered safety data and other in accordance with regulatory requirement, respective SOPs and manuals.
5. Communicate with relevant stakeholder (Health Authority, Site Staff) to clarify enquiry of entered data on the safety database
6. May assist the Medical team to train member from other department on how to collect safety information for Spontaneous safety reporting of marketed product to the company.
7. May assist the team member with safety case monitoring/ Screening activity on safety database.
8. May attend the project team meeting and teleconference as needed.

You are:

E D U C A T I O N , E X P E R I E N C E , S K I L L S AN D K N O W L E D G E R E Q U I R E *** T S QUALIFICATIONS：

• BA/BS/BSc or qualified nurse (RN);
• Medical / Science background with relevant clinical experience Knowledge of medical Terminology
• Excellent communication skill
• Senior Drug Safety Associate - min 3 years’ experience as Drug Safety Associate or related Global/Regional experience

EXPERIENCE & SKILLS

• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

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.