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:
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Degree in Pharmacy, Pharm D, BHMS, BDS or equivalent.
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6+ years of related experience in pharmacovigilance, drug safety, or allied clinical, scientific, or safety domains
Key Responsibilities:
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Lead an operational case processing team, managing daily workload allocation, productivity, and quality across the case lifecycle.
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Oversee case intake, book-in, triage, and validity assessment in line with program SOPs.
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Manage ICSR data entry, MedDRA coding, and narrative writing for cases.
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Oversee E2B submissions, gateway operations, EudraVigilance downloads, and mailbox management where assigned.
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Perform and oversee inline quality control, monitoring error trends and QC metrics.
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Ensure end-to-end case processing meets compliance timelines and quality standards.
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Manage team performance, escalations, training, and development.
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Maintain inspection readiness and support audits and inspections across the case processing function.
Key Skills:
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Case processing team leadership across intake, triage, submission, processing, and QC
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ICSR data entry, coding, narrative writing
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E2B submission and gateway operations
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EudraVigilance and mailbox management
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Inline QC and error trend analysis
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Safety database knowledge – LSMV, Argus Veeva or equivalent
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MedDRA
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Team, workload, and compliance management
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Consumer health
