Senior Drug Safety Associate

(Please submit your resume in English)

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.

Who are you?

You are a forward thinker. Your career trained you to be incredibly thorough and you can track down and document to detail all the relevant facts about an untoward drug effect like a detective. The accuracy and reliability of your work is unquestioned.

You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Drug Safety Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number.
_A place you love working._

Still here? Good. Because if this is you, we’d really like to meet you.

What will you be doing?

As an
_experienced _Drug Safety Associate, you’ll be providing management of ICSRs (individual case study reports), reconciliation of SAEs, and coding and data retrievals from the safety database, just to highlight some of the primary tasks. You’ll also be supporting the generation of aggregated safety reports and Data Monitoring Committee (DMC) reviews.

Additionally, you’ll be writing concise and accurate narratives and performing coding of diseases and medications. You’ll also be participating in quality controls, conducting literature surveillance, developing Safety Management Plans (SMP), and supporting signal detection and risk management activities.

Furthermore, you’ll be interacting with client/sponsor organizations on projects you lead regionally via project team meetings. On the projects you lead, you’ll provide coaching and mentoring to less experienced DSAs.

What you need to have:

- 2+ years of related experience processing ICSRs required
- 3+ years of related experience processing ICSRs desired
- Advanced knowledge in pre
- and post-marketing Pharmacovigilance
- Advanced knowledge in regulatory environment governing safety and risk management activities
- SMP review experience required
- SMP generation and contract review experience desired
- Demonstrated ability to provide leadership for smaller, functional project teams of drug safety associates, including the planning, supervision, and implementation of processes on a project level
- Good written and oral communication skills
- Must read, write and speak fluent English. Multiple language abilities desirable
- To qualify, applicants must be legally authorized to work in Brazil, and should not require, now or in the future, sponsorship for employment visa status.

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 e