Job Description

At Astrix, we're expanding our team to support a diverse range of clients across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to established pharmaceutical companies. Opportunities are available both remotely and on-site throughout the country!



Responsibilities:

• Prepare and review pharmacovigilance documents including:
• Periodic Safety Update Reports (PSURs/PBRERs)
• Risk Management Plans (RMPs)
• Development Safety Update Reports (DSURs)
• Clinical safety narratives
• Signal evaluation and benefit-risk assessment reports

• Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA, etc.), internal SOPs, and quality standards.
• Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics.
• Interpret and synthesize complex clinical and safety data into accurate, concise, and scientifically sound documentation.
• Contribute to the development and maintenance of standard operating procedures (SOPs) and templates for pharmacovigilance documents.
• Monitor regulatory updates and industry trends to ensure documents remain compliant with changing guidelines.
  
  Qualifications:
  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (MS, PhD, PharmD, MD) preferred.
  • Minimum of 3 years of experience in medical writing with a focus on pharmacovigilance or regulatory affairs.
  • Strong knowledge of drug safety regulations and pharmacovigilance systems.
  • Proficiency with safety databases, literature databases (e.g., PubMed, Embase), and standard writing tools (e.g., Microsoft Word, Excel).
  • Excellent written and verbal communication skills with attention to detail.
  • Ability to manage multiple projects and work independently under tight deadlines.
  
  This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
  
  
  #INDBH

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