Senior Drug Safety Associate

Senior Drug Safety Associate

JR104765

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:

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.

Responsibilities:

• As a Snr DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners.

• Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.

• Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.

• Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors

What you will need:

• The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.• Must be fluent in written and verbal local language with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.• Medical/science background and/or bachelor’s degree or local equivalent.

Advanced English for Writing / Reading / Speaking

Degree in Health is a plus

Note: The position can be homeworker or hybrid

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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