Case Specialist

• Perform quality control of vigilance cases
• Conduct medical evaluation of reports and files
• Enter vigilance case data into ad hoc databases or other client-agreed formats
• Request case follow-up by phone and email
• Pre-analyze complex cases before data entry
• Evaluate coding, causality, expected/listed status, seriousness, and submission requirements
• Validate documents produced by Data Managers, Vigilance Associates, and documentalists
• Close vigilance files
• Identify requirements and applicable changes for ICSR/MLM filters
• Analyze inclusion and exclusion of EV/MHRA cases
• Perform quality control for clinical and post-marketing cases
• Act 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, adverse event reporting, and causality assessment
• Knowledge of current regulations
• Process-oriented
• Rigorous and able to work in a team
• Microsoft Office proficiency
• Ability to multitask
• Flexibility
• Excellent communication skills

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