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R0000038960 Patient Safety Associate I (Drug Safety Associate I)

June 2, 2026

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Make a Meaningful Impact in Global Patient SafetyAt Parexel, we’re dedicated to improving patient health worldwide. As a Patient Safety Associate I, you’ll play a vital role in supporting drug safety, clinical trials, and post‑marketing surveillance activities in post-market surveillance, with some exposure to clinical trials, ensuring full compliance with regulatory requirements and Standard Operating Procedures (SOPs).As a Patient Safety Associate I, you'll be responsible for several key activities including processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency, conducting comprehensive literature searches and reviews to identify safety signals, and supporting signal detection and management activities. You'll track and monitor regulatory information updates, assist in preparing and executing regulatory submissions, and contribute to the development of aggregate reports and study-specific safety documents. Where applicable, you'll also manage Medical and Product Dictionary activities. Your role will be crucial in maintaining compliance through quality reviews of safety deliverables, generating metrics and performance indicators for safety operations, investigating and documenting late deliverable incidents, and ensuring adherence to international and local regulatory reporting requirements.We're looking for candidates with strong attention to detail and commitment to quality, an understanding of drug safety regulations and pharmacovigilance principles, excellent organizational and time management skills, the ability to work collaboratively in a team environment, and strong written and verbal communication skills. Join a global leader in Clinical Research Organization services, where you'll contribute to improving patient safety worldwide while developing your career in pharmacovigilance.What You’ll Do:General Safety Operations<ul><li>Follow project-specific procedures and regulatory standards.</li><li>Support basic compliance activities, documentation, metrics, and audit preparation.</li><li>Work collaboratively with team members and complete required training programs.</li></ul>ICSR (Individual Case Safety Report) Processing<ul><li>Review, triage, and process safety reports from various sources.</li><li>Perform data entry in safety databases with accuracy and medical consistency.</li><li>Assist with follow-ups, case narrative preparation, MedDRA coding, and quality checks.</li><li>Support compliance investigations and metrics reporting.</li><li>Prepares medically cohesive case narratives based upon the reported information.</li></ul>Safety Submissions<ul><li>Submit ICSRs and periodic safety reports to Health Authorities and stakeholders.</li><li>Maintain regulatory submission schedules and reporting rules.</li><li>Assist in audit preparation and regulatory intelligence updates.</li><li>Support global reporting configuration and compliance activities.</li></ul>Literature Search & Review<ul><li>Develop and maintain literature search strategies.</li><li>Screen published articles for potential safety signals or adverse events.</li><li>Conduct quality checks and manage journal reviews.</li><li>Collaborate with internal teams for full-text retrieval and assessment.</li></ul>Affiliate Services<ul><li>Support communication between global operations and local safety affiliates.</li><li>Assist with safety information exchange, translations, and compliance tasks.</li><li>Conduct literature monitoring and data reconciliation activities.</li></ul>Regulatory Support<ul><li>Maintain regulatory systems and product registrations.</li><li>Assist with submissions (eCTD), renewals, variations, and lifecycle management.</li><li>Verify data accuracy and generate quality and compliance reports.</li></ul>Regulatory Intelligence<ul><li>Research and maintain global safety reporting requirements.</li><li>Update regulatory intelligence databases and trackers.</li><li>Support day-to-day operations within the Global Pharmacovigilance Intelligence Office.</li></ul>Your Knowledge & Experience:<ul><li>Foundational knowledge of drug safety regulations and pharmacovigilance processes. Ideal candidate has 3+ years experience in Drug Safety.</li><li>2+ years experience in a post marketing.</li><li>Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease).</li><li>Strong attention to detail, organizational skills, and problem‑solving ability.</li><li>Effective communication and willingness to work in a collaborative team environment.</li><li>Proficiency with MS Office and ability to learn safety systems/databases. Preference for those with Veeva Safety experience.</li></ul>Education<ul><li>Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience.</li></ul>This role offers the flexibility to work from home in the US.#LI-KS1EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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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...