• Plan and execute report management activities, including data collection, strategy development, and kick-off/round-table meetings.
  
  
• Author or co-author global safety reports such as Annual Reports, PSURs, PADERs, DSURs, Risk Management Plans, and other regulatory documents.
  
  
• Perform quality reviews of reports prepared by junior or associate writers.
  
  
• Prepare ad hoc reports, benefit-risk evaluations, and supporting documents for label updates.
  
  
• Write Common Technical Document (CTD) summaries including Non-Clinical and Clinical Overviews, Clinical Summaries, and related regulatory documents.
  
  
• Draft medical information responses for healthcare professionals.
  
  
• Contribute to signal detection and safety issue analysis reports.
  
  
• Write adverse event narratives for serious adverse events and adverse drug reactions.
  
  
• Support labeling activities (e.g., CDS, USPI, SPCs, Med Guides).
  
  
• Conduct and review literature searches, prepare abstracts/summaries, and propose company comments.
  
  
• Ensure compliance with regulatory requirements, GVP, ICH-GCP guidelines, and SOPs.
  
  
• Promote efficient, consistent, and quality processes while maintaining accountability for deliverables.
  
  
• Foster excellent internal and external client relationships through timely, high-quality service.
  
  

Perform additional duties as per project requirements or manager’s direction.