Medical Writer I, Patient Safety

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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

• Lead or independently contribute, with supervision, to scheduled and ad-hoc aggregate safety reports and documentation • Prepare and compile PSURs, PBRERs, ACOs, DSURs, PADERs, SASRs, ARBE reports, and safety statements • Incorporate team review feedback and conduct quality reviews for consistency and data integrity • Coordinate submissions of safety documents to regulatory authorities across multiple regions • Generate comparison documents, INN checks, and appendices • Perform signal detection by collecting and analyzing data from databases, clinical sources, literature, and regulatory websites • Conduct quantitative and qualitative safety analyses to identify potential safety signals • Manage signal tracking and maintain signal logs • Prepare signal assessment documents, Drug Safety Reports, and Signal Evaluation Reports • Conduct literature searches and review publications for signal evaluations, PSRs, and epidemiology reports • Identify and resolve data discrepancies in line listings and other safety data sources • Assist with preparing and updating Risk Management Plans and related documents • Provide scientific support based on product safety profiles and therapeutic areas • Communicate task progress, address challenges, and manage timelines • Maintain audit-ready documentation, archive source materials and communications, and support inspection readiness • Manage routine client interactions, document cycles, status updates, and client-specific requirements • Collaborate across functions and with global stakeholders • Apply global regulatory requirements and quality control practices • Monitor KPIs and SLAs, participate in audit readiness, and contribute to continuous improvement • Complete advanced training and support process improvements through technology and practical guidance

🎯 Requirements

• Prior experience in pharmacovigilance or related fields is preferred • Good understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts • Proficiency in medical terminology and pharmacovigilance coding dictionaries, including MedDRA and WHO-DD • Proficiency in medical writing tools and Microsoft Office applications • Familiarity with pharmacovigilance databases and coding dictionaries • Analytical thinking and problem-solving skills for interpreting complex safety data • Scientific writing and communication expertise • Strong collaboration and interpersonal skills for cross-functional, global teams and client interactions • Excellent organizational and time-management skills • Ability to prioritize tasks, manage multiple projects, and meet deadlines • Adaptability and continuous learning mindset • Preferred university degree in Life Sciences, Health, or Biomedical Sciences, such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy, or equivalent combination of training and work experience • Clinical exposure in hospital-based environments is advantageous

🏖️ Benefits

• Full-time employment • Training and development opportunities • Advanced training • Practical guidance and collaboration to improve team efficiency