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Senior Drug Safety Specialist

May 26, 2026

<h2>Drug Safety Specialist / Senior Specialist – Job Summary</h2>We are looking for a Sr Drug Safety Specialist based in Brazil to work remote and support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and post‑marketing sources, ensuring timely and compliant submissions to global regulatory authorities.<div></div><h2>Key Responsibilities</h2><ul><li>Process ICSRs, including case validation, day‑zero determination, review of source documents, and escalation of special safety situations.</li><li>Perform medical coding, narrative writing, listedness assessments, follow‑up determination, and Analysis of Similar Events.</li><li>Ensure workflow compliance by reviewing safety database timelines and case progression.</li><li>Conduct reconciliation between clinical trial databases and safety systems.</li><li>Execute due diligence activities, including query distribution and follow‑up with external reporters.</li><li>Contribute to compliance, productivity, and quality performance metrics.</li><li>Support continuous improvement initiatives and inspection readiness.</li><li>Make operational decisions aligned with SOPs, work instructions, and regulatory standards.</li></ul><div></div><h2>Required Knowledge & Experience</h2><ul><li>Understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA, MHRA, NMPA, etc.).</li><li>Experience with safety databases and case processing (intake, triage, coding, narratives, due diligence).</li><li>Clinical knowledge of therapeutic areas and drug classes (preferred).</li><li>Strong time‑management skills and attention to detail.</li><li>Ability to collaborate with Safety Operations, Medical Review, Clinical Operations, Product Safety Leads, and other stakeholders.</li></ul><div></div><h2>Education & Experience Requirements</h2><ul><li>Bachelor’s degree in Life Sciences, Nursing, Pharmacy/PharmD, or other healthcare‑related field; equivalent education or professional experience accepted.</li><li>Advanced English (Mandatory) Advanced Spanish (preferred)</li><li>Minimum 1 year of experience in drug safety/pharmacovigilance or relevant clinical experience (training included).</li><li>Previous experience in the pharmaceutical industry preferred.</li></ul>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at <a href="https://jobs.iqvia.com/" target="_blank" rel="noopener noreferrer">https://jobs.iqvia.com</a>IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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