Patient Safety Associate I – Drug Safety Associate I

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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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, follow-up activities, and case narrative preparation in safety databases • Support regulatory reporting 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 • Submit Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and 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 • Maintain regulatory databases, track submissions, support registrations, and assist with lifecycle management • Research, maintain, and update country-specific safety reporting requirements and associated records • Participate in project meetings, training programs, audits, inspections, and departmental activities • Escalate issues to supervisors as appropriate • Collaborate with experienced professionals across global teams to support patient safety and pharmacovigilance activities

🎯 Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or 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, including cardiology, neurology, oncology, and 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 Microsoft Office • Ability to learn safety systems/databases • Preference for Veeva Safety experience • Experience working with pharmacovigilance systems, databases, and established workflows • Interest in pharmacovigilance, patient safety, pharmaceutical development, or healthcare environments • Commitment to quality and compliance

🏖️ 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 • Additional benefit offerings in accordance with the terms of applicable plans • Work from home flexibility in the US