Responsible for the distribution of SUSARs/SUSAR Line Listings and DURs to Ethics Committees and Investigators.
What you will be doing:
- Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
- Operational support for SUSAR/SUSAR LL/DSUR case distribution via safety reporting systems according to the Global Safety Reporting´s current processes.
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Reconciliation with safety partners and compliance analysis- Support changes to departmental documentation as needed.
- Communication with the service users and all involved partners
- Support CAPA investigations and or action plans as needed.
- Support ongoing department projects as required.
- Co-monitoring of key processes
You are:
- Creating periodic notifications to the service users
- Acting as business owner delegate
- Providing expertise related to the outbound safety reporting processes
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.
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.
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.
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