ABOUT MEDICAL SAFETY WRITER
Pharmacovigilance Medical Writers/Medical Safety Writers are amongst the most demanding professionals in the Pharmacovigilance industry where they play a crucial role at every stage of the drug development process. The industry requires highly skilled professionals for writing safety reports within agreed timeframes and to a high standard of accuracy. The scope of the position starts from clinical development till post marketing activities and pharmacovigilance medical writing is a necessary element at every stage. This generates the demand of specialised writers for successful submissions of regulatory documents in compliance with international guidelines.
MEDICAL SAFETY WRITER TRAINING
This training program covers all the technical and regulatory aspects of Medical Safety Writer Job and the participant gets hands on experience on writing and review of various regulatory safety reports.
• DSURs
• IND Annual Reports
• Clinical SAE narratives
• Summary of Clinical Safety (CTD Module)
• Clinical Overviews (overview of safety)
• EU RMPs
• US REMS
• Integrated Summary of Safety
• EU PSURs/PBRERs
• US PADERS/PAERs
• 120-Day Safety Update Reports
• Clinical Overview Addenda (ACO)
• Ad hoc reports including safety reviews & summaries
• RSI variations & documentations
AT THE END OF THE TRAINING YOU WILL BE ABLE TO
- Author safety reports independently for medicinal products including collection organization, analysis, presentation the data (line listings and summary tabulations) and drafting of safety medical evaluations by means of standard operating procedures.
- Lead safety writing projects to develop new writing processes for regulatory reports in alignment with international regulations
- Author safety reports independently for medicinal products including collection organization, analysis, presentation the data (line listings and summary tabulations) and drafting of safety medical evaluations by means of standard operating procedures.
