Job Overview
Location
United States - Remote
Job Type
Full-time
Category
Software Engineering
Date Posted
June 14, 2026
Full Job Description
đź“‹ Description
- • Process Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and medical consistency, including data entry into safety databases and preparation of medically cohesive case narratives.
- • Review, triage, and manage safety reports to ensure timely and compliant handling according to regulatory standards and Standard Operating Procedures (SOPs).
- • Perform comprehensive literature searches and reviews to identify potential safety signals or adverse events, including screening published articles and managing journal reviews.
- • Support global regulatory submissions of ICSRs and periodic safety reports to Health Authorities, maintaining submission schedules and adherence to reporting rules.
- • Assist in preparing and executing regulatory documentation, including eCTD submissions, renewals, variations, and product lifecycle management activities.
- • Conduct quality checks on safety deliverables, investigate late deliverable incidents, and generate metrics and performance indicators for safety operations.
- • Support signal detection and management activities through data analysis, case review, and collaboration with cross-functional teams.
- • Manage Medical and Product Dictionary activities, including MedDRA coding and data reconciliation tasks.
- • Maintain regulatory intelligence databases and trackers, researching and updating global safety reporting requirements across international jurisdictions.
- • Collaborate with global operations and local safety affiliates to facilitate safety information exchange, translations, and compliance tasks.
- • Support audit preparation and regulatory intelligence updates, ensuring alignment with international and local pharmacovigilance regulations.
- • Participate in required training programs and follow project-specific procedures to maintain compliance and operational excellence.
- • Work within global pharmacovigilance systems to ensure accurate data capture, reporting, and documentation across clinical and post-marketing phases.
- • Contribute to the development of aggregate reports and study-specific safety documents under supervision of senior team members.
- • Utilize MS Office applications and learn proprietary safety systems, with preference given to experience with Veeva Safety.
- • Maintain accurate records of product registrations and regulatory systems to support ongoing compliance and reporting obligations.
- • Ensure adherence to quality standards through meticulous attention to detail, documentation, and timely completion of assigned tasks.
- • Support the Global Pharmacovigilance Intelligence Office in day-to-day operations related to regulatory updates and safety monitoring.
🎯 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
- • 3+ years of experience in Drug Safety
- • 2+ years of experience in post-marketing pharmacovigilance
- • Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
- • Proficiency with MS Office and ability to learn safety systems/databases; preference for Veeva Safety experience
🏖️ Benefits
- • Remote work flexibility within the United States
- • Opportunity to contribute to global patient safety initiatives
- • Career development in pharmacovigilance within a leading Clinical Research Organization
- • Collaborative team environment with global exposure
- • Exposure to diverse therapeutic areas and regulatory landscapes
- • Participation in required training programs to enhance professional skills
Skills & Technologies
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About Parexel International Corporation
Parexel provides global biopharmaceutical services, managing Phase I-IV clinical trials, regulatory consulting, market access, and real-world evidence studies for drug and device development. The company supports sponsors in trial design, site selection, patient recruitment, data management, biostatistics, pharmacovigilance, and health economics. Operating in over 100 countries, Parexel integrates therapeutic expertise with technology platforms to accelerate approvals and improve evidence generation. Services span oncology, neurology, rare diseases, and vaccines, combining decentralized trial capabilities, digital health tools, and post-marketing surveillance to optimize development timelines and commercial success.
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