Safety Assistant

Safety Assistant

JR105807

Site: São Paulo -  Brazil

 
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.

As a Senior Drug Safety Associate at ICON, you’ll work within a large-scale, fast-paced environment. As part of our Safety Reporting Group in ICON, our DSA’s contribute to our culture of process improvement, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

Overview:

The Safety Assistant performs a variety of administrative duties within the business unit, including but not limited to distribution of incoming serious adverse event (SAE) / adverse reaction (AR) information, scanning and photocopying of safety related documents, tracking of safety related information, organizing and maintaining files, preparation of documents and reports, compiling records, and posting information. The Safety Assistant may serve as the primary staff assistant to a department and/or project teams.

Responsibilities:

Receives incoming reports for the department (including but not limited to documents received via fax server and safety email inboxes) and distributes the reports to the appropriate project teams. • Scans received documents for unrequested personal identifiers and initiates appropriate actions to protect data privacy. • Prepares courier shipments (including printing of address labels and copying of attachments). • Maintains project specific address data for courier applications. • Sends reports/submissions/queries via fax or email. • Scans documents into the electronic Trial Master File (eTMF). • Processes safety related documents in eTMF workflows. • Tracks status in safety systems (Safety Letter Tracker System, Safety Case Tracker, Safety Database, etc.). • Assists in the quality control of paper and electronic files. • Runs reports from internal systems (e.g. InfoView) and distributes them to the project team or departmental managers. • Reviews query aging reports and initiates reminders or escalations of queries. • Participates in the translation management process as assigned. • Responds to staff requests for administrative support as needed. • Answers phones and forwards calls to the appropriate project team member. • Adheres to company policies and procedures including corporate guidelines and best practices. • Follows-up on cases as appropriate

What you will need:

•      Microsoft Office

•      Advanced English for Writing / Reading / Speaking

•      A high school diploma and/or equivalent.

·         Desirable 1 year of exp.

·         Degree in Health is a plus

To be successful in the role, you will have:

Benefits of Working in ICON:

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.

At 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.

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, 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.

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