Patient Safety Associate I – Drug Safety Associate I

🔥 22 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data • Perform data entry, case creation, case processing, quality checks, coding activities, follow-up activities, and case narrative preparation within safety databases • Support compliance with regulatory reporting requirements through accurate processing, documentation, reconciliation, and tracking of safety cases and submissions • Conduct literature searches, screen and review scientific literature, identify potential safety information, and support literature monitoring activities • Manage submission of Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and other stakeholders • Support affiliate services, including safety information exchange, literature screening coordination, translation support, follow-up activities, and data reconciliation • Maintain documentation, records, and project files in EDMS and eTMF environments • Support regulatory operations by maintaining regulatory databases, tracking submissions, supporting registrations, and assisting with lifecycle management activities • Participate in regulatory intelligence activities by researching, maintaining, and updating country-specific safety reporting requirements and associated records • Participate in project meetings, training programs, audits, inspections, and other assigned departmental activities • Escalate issues to supervisors as appropriate

🎯 Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience • Foundational knowledge of drug safety regulations and pharmacovigilance processes • Ideal candidate has 3+ years experience in Drug Safety • 2+ years experience in post marketing • Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease) • Strong attention to detail, organizational skills, and problem solving ability • Effective communication and willingness to work in a collaborative team environment • Proficiency with MS Office and ability to learn safety systems/databases • Preference for those with Veeva Safety experience • Experience working with pharmacovigilance systems, databases, Microsoft Office applications, and established workflows

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Flexible work from home arrangement in the US