Safety Support

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.

The role:

- Provide support in the AE/AESI/SAE case management in order to ensure all forms (initial and follow-up), and any additional information received at CSU level, are forwarded to Global Pharmacovigilance (GPV) according to the timelines defined in GPV Quality Documents, including:

- Handling of Cluster safety mailbox
- Identification of the case
- Check, review and track mínimal information
- If necessary, contact CRA or CSU SL for clarification
- Management of Translation of hospital reports
- Send AE/AESI/SAE docs to GPV.
- Reception of acknowledgement of receipt
- Electronica filing of all safety documentation
- Provide support in order to check and ensure that all questions from GPV which have been received in the safety mailbox are distributed to corresponding monitoring team and solved accordingly.

SUSAR management (Dear investigator letter(DIL)/Semi-annual Safety Report (SASR))
- Provide support in order to ensure that Dear Investigators Letters (DIL)/Semi-annual Safety Report (SASR)) received from GPV are forwarded to investigators.
- Train CPAs in the correct management and electronic filing of DILs.

DSUR/ SASR Management (periodic safety report)
- Provide support in order to ensure that the periodic safety reports received from GPV are transmitted to IRB / EC in accordance with the local law and Quality Documents.
- Tracking and filing of applicable documentation..

Generalities
- Assist the CSU SL in any other safety tasks/activity.
- Set up and maintain the eTMF filing.
- Data entry and maintenance of tracking tool(s).
- Ensure MT is properly trained on management of safety reporting and safety related documents, together with CSU SL
- Perform administrative duties as assigned by management.

**Requirements**:

- Background: Diploma - Secondary education or equivalent
- Knowledge: Good knowledge of all relevant QDs, guidelines, local and international regulations, and Good Clinical Practices.
- Language _(language and knowledge level_): English -Fluency in English, spoken and in writing for communication with international team and especially with GPV.
- Professional experience: Minimum 2-4 years of professional experience in Clinical Development or Clinical Research.

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.