Regulatory Medical Writer
4 days ago
Job Summary:
As a Regulatory Medical Writer at Parexel, you will play a vital role in ensuring the accuracy and quality of safety reports and regulatory submissions. Your primary responsibility will be to manage and prepare various aggregate reports, including Periodic Safety Reports (PSRs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
Key Responsibilities:
- Manage and prepare aggregate reports, including PSRs, PBRERs, and DSURs, in accordance with client requirements and regulatory guidelines
- Conduct critical appraisal and systematic review of literature to support the background rates of issues under evaluation
- Develop literature search strategies for the epidemiology section of safety reports
- Apply epidemiological methods and calculations to data available in literature to support the background rates of issues under evaluation
- Generate Line Listings for submissions and ensure data consistency and integrity across the document
- Perform aggregate report compliance activities, including quality review to check the data/facts and internal consistency
- Distribute final reports to stakeholders, including partners, affiliates, and submission to health authorities
- Support signal detection and evaluation activities, including signal tracking, signal assessment/data analysis, and leading review meetings
- Collaborate with the safety science team to conduct signal detection reviews and analysis
Requirements:
- Relevant experience in Regulatory/Pharmacovigilance or related field is desirable
- Good knowledge of medical terminologies and international drug safety regulations
- Science/Medicine degree, with a minimum qualification of a university degree in life Sciences/Health or Biomedical Sciences
- Excellent analytical and problem-solving skills, with the ability to work effectively in a team environment
- Excellent verbal and written communication skills, with the ability to evaluate data and draw conclusions independently
- Fluency in written and spoken English, with proficiency in IT skills and the ability to work with web-based applications
Work Environment:
Parexel is a leading global biopharmaceutical solutions organization dedicated to providing a comprehensive range of expertise, technologies, and services to support the development and commercialization of innovative new treatments. Our company is committed to delivering high-quality work products and services to our clients, while fostering a collaborative and inclusive work environment that values diversity and promotes employee growth and development.
How to Apply:
Apply now to join our team of talented professionals and help us deliver excellence in regulatory medical writing and pharmacovigilance services. We look forward to hearing from you
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