Pharmacovigilance Associate

Role & responsibilities

• Data Entry of ICSRs in Pharmacovigilance database. Entering source data in the database, Coding, Narrative(s) writing and Generate Follow-up letters.
  
• Book in and Triaging of ICSRs
  
• Review of literature articles and assessment for identifying valid ICSRs (if applicable)
  
• Quality Check of ICSRs in database (if applicable)
  
• Support in preparation of aggregate reports (if applicable)
  
• Support in Signal detection of the ADRs with cases received from client's products (if applicable)
  
• Compliance to project guidelines
  
• Execution of Company Standard Operating Procedures
  
• Builds and maintains good relationships across functional units and company affiliates
  
• Maintain awareness of changes to/new regulations affecting PVG activities
  
• To carry out necessary administrative duties required for the job
  
• Other duties as assigned by management
  

Preferred candidate profile