Medical Writer (Contractor)

📋 Description

• Analyze and interpret safety data: Review clinical and non-clinical safety data, alongside relevant
• Prepare aggregate safety reports: Author and review periodic and development safety reports
• Develop risk management documentation: Prepare and review Risk Management Plans (RMPs) and related
• Author clinical and regulatory documents: Develop and review Clinical Study Reports, clinical study
• Conduct signal detection and assessment: Perform qualitative and quantitative signal assessments to
• Conduct scientific literature reviews: Search, assess, and summarize relevant scientific

🎯 Requirements

• Bachelor's degree or equivalent qualification in life sciences, pharmaceutical sciences, medicine
• At least two years of professional medical writing experience, ideally within pharmaceutical
• Familiarity with authoring and reviewing aggregate safety reports, including PSURs, PBRERs, DSURs
• Understanding of drug safety regulations, pharmacovigilance practices, safety surveillance, risk
• Experience preparing or reviewing Risk Management Plans, Clinical Study Reports, clinical
• Ability to review and interpret clinical and non-clinical safety information, conduct literature

🎁 Benefits

• Competitive hourly compensation based on medical writing and drug safety experience.
• Remote working arrangement.
• Flexible, as-needed contract engagement, with assignments and extensions defined through a Scope of
• Opportunity to contribute to pharmaceutical product safety, clinical development, and regulatory
• Exposure to diverse pharmacovigilance activities, scientific documentation, and regulatory
• Collaboration with experienced drug safety professionals, clinical research teams, and regulatory