Pharmacovigilance /Drug Safety Roles at Golden Opportunities Private Limited

Urgent
Posted 6 months ago
Kolkata, West Bengal
Application deadline closed.

Job Description

Pharmacovigilance /Drug Safety Roles

Golden Opportunities Private Limited

Job title: Data AnalystLocation: Kolkata
Education: Bachelor’s or Master Degree in Bio-science or Pharmacy
Experience: Minimum 1 year of PV experience
Candidate specification: Knowledge of coding applications databases processes and tools is required

Job Description:
• Receive cases in Data entry workflow
• Check source document
• Data entry in all required fields in Argus referring source document
• Escalation to DSI for any discrepancies regarding the source document
• Extract events from source document
• Perform Event coding (MedDRA) and Drug coding (WHODD)
• Generate queries if required
• Modify narrative as per conventions
• Use Auto narrative template to generate narrative
• Enter only Reporter causality as reported
• Assess Company causality
• Perform Labeling as per current approved Labeling document
• Enter seriousness criteria or upgrade as needed
• Route to Medical review
• Excellent written and verbal communication including professional documentation skills
• Excellent… ability to prioritize tasks meet deadlines and work under changing conditions and high pressure