Role & Responsibilities
• Perform quality control (QC) of pharmacovigilance cases
• Conduct medical evaluation of adverse event reports
• Enter vigilance case data into agreed databases and formats
• Perform follow-up of cases via phone and email
• Pre-analyse complex cases prior to data entry
• Evaluate cases for medical coding as per applicable dictionaries
• Assess causality between suspect product and reported events
• Determine seriousness and expectedness of events
• Identify regulatory submission requirements for each case
• Validate documents prepared by Vigilance Associates or Data Managers
• Close vigilance case files in compliance with timelines
• Support setup and review of ICSR / MLM filters
• Analyse inclusion or exclusion of EV / MHRA cases
• Provide medical input to the Medical Information division
• Support client-specific pharmacovigilance activities within the business unit
Qualification
• Doctor (MBBS or equivalent) or Pharmacist by training
Experience
• Minimum 3 years’ experience with service providers in pharmacovigilance
• Hands-on experience in QC of safety cases
• Experience with SafetyEasy database (mandatory)
Skills
• Strong knowledge of global pharmacovigilance regulations
• Experience working with safety databases
• Process-oriented and detail-focused approach
• Ability to multitask and manage multiple priorities
• Proficiency in Microsoft Office tools
• Excellent written and verbal communication skills in English
• Strong teamwork and collaboration skills
• Flexible and adaptable in a dynamic environment
About the Company
• ProductLife Group is a global life sciences consulting and services company , Supports pharmaceutical, biotech, and medical device companies across the product lifecycle.
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