Team Lead - Case Processing

Job Overview:

Team leader accountable for case processing operations within a large-volume OTC/consumer healthcare pharmacovigilance program. Reports to the Case Management Lead and leads an operational team across the end-to-end case lifecycle, including intake, triage, submission, processing, and quality. Team Leads are deployed flexibly across these areas based on operational need.

Qualification and Experience:

• Degree in Pharmacy, Pharm D, BHMS, BDS or equivalent.
• 6+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains

Key Responsibilities:

• Lead an operational case processing team, managing daily workload allocation, productivity, and quality across the case lifecycle.
• Oversee case intake, book-in, triage, and validity assessment in line with program SOPs.
• Manage ICSR data entry, MedDRA coding, and narrative writing for cases.
• Oversee E2B submissions, gateway operations, EudraVigilance downloads, and mailbox management where assigned.
• Perform and oversee inline quality control, monitoring error trends and QC metrics.
• Ensure end-to-end case processing meets compliance timelines and quality standards.
• Manage team performance, escalations, training, and development.
• Maintain inspection readiness and support audits and inspections across the case processing function.

Key Skills:

• Case processing team leadership across intake, triage, submission, processing, and QC
• ICSR data entry, coding, narrative writing
• E2B submission and gateway operations
• EudraVigilance and mailbox management
• Inline QC and error trend analysis
• Safety database knowledge - LSMV, Argus Veeva or equivalent
• MedDRA
• Team, workload, and compliance management
• Consumer health