Drug Safety Associate Jobs in Mysore - BIOCLINICA

As Case Intake Member: 

• Responsible for case intake, duplicate check , and registration
• Maintain log of source documents and other communications

As Case Processor:

• Responsible for data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures
• Process all incoming cases in order to meet timelines
• Full data entry including medical coding and safety narrative

As Medical Coder

• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)

As Narrative Writer

• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

As Literature Review Specialist

• Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
  
• Review of literature articles to identify case safety reports.
  
• Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
  
• Assist in signal generation and safety analysis activities.
  
• Ensure quality of literature searches and reporting.
  
• Review of local/global literature reports to determine regional reportability.
  
• Create/maintain study summary documents.
  
• Assist with narrative writing for periodic/ad hoc submissions.
  
• Assist with ad hoc or routine safety monitoring activities.