Case Specialist

• Perform quality control of vigilance cases
• Conduct medical evaluation of reports
• Enter vigilance cases into ad hoc databases or other client-agreed formats
• Make follow-up requests for vigilance cases by phone and email
• Pre-analyze complex cases before data entry
• Evaluate coding according to applicable dictionaries
• Assess causal relationships between effects and suspect products according to applicable methods
• Determine whether events, effects, or incidents are expected/listed or unlisted
• Assess seriousness of events, effects, incidents, and cases
• Identify submission requirements for each case
• Validate documents produced by Data Managers, Vigilance Associates, and documentalists
• Close vigilance files
• Identify requirements and applicable changes for ICSR/MLM filters
• Analyze inclusion/exclusion of EV/MHRA cases
• Perform QC for clinical and post-marketing cases
• Serve as key contact for specific customers with support from an Activity Manager or Line Manager

• Doctor in Pharmacy/ Pharmacist by training
• Minimum 3 years of experience in a similar position
• Previous experience working to deadlines
• Database experience
• Clinical and Post Marketing case processing experience
• Pharmaceutical background with strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
• Deep knowledge of pharmacovigilance principles and adverse event reporting
• Experience with causality assessment
• Knowledge of current regulations
• Proficiency with Microsoft Office tools
• Ability to multitask
• Flexibility
• Excellent communication skills
• Ability to work in a team
• Process-oriented and rigorous approach

• Career growth opportunities
• Opportunity to make a meaningful impact on global healthcare
• Collaboration with an innovative, forward-thinking global team
• Purpose-driven work
• Ability to work remotely