Patient Safety Associate II

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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

• Process and manage Individual Case Safety Reports (ICSRs), including data entry, case assessment, MedDRA coding, narrative writing, follow-up, reconciliation, and quality checks • Support regulatory safety submissions, periodic reports, and compliance tracking to health authorities • Conduct literature searches and screening to identify adverse events, safety signals, and reportable cases • Coordinate with global affiliates on safety reporting, local compliance requirements, translations, and data exchange • Assist with regulatory support activities, product registrations, safety database updates, and regulatory intelligence monitoring • Ensure adherence to SOPs, regulatory timelines, quality standards, and client requirements • Participate in audits, inspections, process improvements, metrics reporting, and training activities • Collaborate with cross-functional teams and support client interactions as required

🎯 Requirements

• Basic knowledge of pharmacovigilance, drug safety regulations, ICH guidelines, and regulatory reporting • Good understanding of medical terminology and safety databases • Strong analytical, communication, organizational, and problem-solving skills • Proficiency in MS Office and PV systems • Degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, Dentistry, or related field • 4+ years of experience in pharmacovigilance, safety case processing, or regulatory reporting preferred